Respond to recalls

The recalls process allows recall coordinators and pharmacy technicians to collaborate with their internal locations and external Partners to respond to and monitor recalls issued by the FDA that they are potentially impacted by. Submitting recall responses to TraceLink enables companies to easily track a recall's progress and provides a hub for all of their location's responses to a recall, which can then be exported and sent to the recalling company for FDA effectiveness reporting. Additionally, companies that own APT can use the recalls process to communicate with their locations or external Partners about a recall and send follow-up messages reminding locations of approaching or overdue response deadlines. For example, a recall coordinator for a retail pharmacy can use the recall's progress to monitor the state of all recalls their company is potentially impacted by, drill down into a recall with an approaching response deadline, and notify only the locations that have not yet responded to the recall that their response is due in 3 days. Locations that receive that notification can then use TraceLink to submit the required responses (i.e. acknowledgment, impact, quantity, and completion) to the recall before the deadline and export them to send to the recalling company.

Submit recall responses

Recall coordinators or pharmacy technicians for a location can submit acknowledgment, impact, quantity, and completion responses to TraceLink for each of their locations. Additionally, locations that are not impacted by a recall can opt-out of it. Submitting recall responses allows locations to quickly and effectively determine how a recall impacts them and communicate that impact to the rest of their company reducing the time and effort required to respond to and manage recalls.

Recall coordinators for a company or location can assign a recall to the user who is responsible for submitting a specific location's responses to the recall.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the recall.
  7. Select the Action icon in the row for the recall.
  8. Select Assign to User.

  9. In the Assign to User panel:

    1. Enter the name of the User at your company or location that is responsible for responding to the recall.
    2. Select Assign.

      The recall is assigned to the selected user.

Tips

  • A recall can also be assigned to a user from the View Recall [TraceLink Recall ID] screen using the Action icon in the top right of the screen.

Recall coordinators or pharmacy technicians can opt out of a recall on behalf of their location indicating they do not carry any of the products in the recall and that the recall does not affect them.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the recall.
  7. Select the Action icon in the row for the recall.
  8. Select Opt Out.

  9. Enter the Reason for opting out of the recall in the confirmation dialog box (optional).

  10. Select Opt Out.

    The location is opted out of the recall and its Response Status is updated to Opted Out.

Tips

  • If a recall is opted out of accidentally, select Opt In from the Action icon menu to opt back into the recall.
  • A recall can also be opted out from the View Recall [TraceLink Recall ID] screen using the Action icon in the top right of the screen.

Recall coordinators or pharmacy technicians can submit an acknowledgment response to a recall on behalf of their location indicating they have been made aware that products they dispense are being recalled.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the recall.
  7. Select the Action icon in the row for the recall.
  8. Select View Recall.
  9. Select Acknowledge in the Recall Summary panel.

  10. Select Acknowledge in the confirmation dialog box.

    The acknowledgment response is submitted for the location and its Response Status is updated to In Progress.

Tips

  • A recall can also be acknowledged from the View Recall [TraceLink Recall ID] screen using the Action icon in the top right of the screen.
  • Once a recall is acknowledged, it cannot be opted out of.

Recall coordinators or pharmacy technicians can submit the impact and quantity responses for each product in a recall on behalf of their location indicating whether or not they have any of the recalled products in stock, and if so the quantity they have on hand to return to the recalling company.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the recall.
  7. Select the Action icon in the row for the recall.
  8. Select View Recall.

  9. Select View Full Details in the Recall Summary panel.

  10. Select the View icon for Product Number 1 in the Product Details table.

  11. In the Inventory Impacted section, select whether the location has any of the product in stock from the Inventory Impacted drop-down.

  12. If the location's inventory is impacted, in the Quantity of Product Affected section for each Pack Size:

    1. Enter the amount of that packaging size in the location's inventory in the Quantity on Hand field.
    2. Select the Unit of Measure for the quantity entered in the Quantity on Hand field:
      • Ampoule – The product is measured in ampoules.
      • Bundle – The product is measured in bundles.
      • Bag – The product is measured in bags.
      • Bottle – The product is measured in bottles.
      • Box – The product is measured in boxes.
      • Bulk Box – The product is measured in bulk boxes.
      • Card or Blister – The product is measured in cards or blisters.
      • Centiliter – The product is measured in centiliters.
      • Capsule – The product is measured in capsules.
      • Case – The product is measured in cases.
      • Cubic Centimeter – The product is measured in cubic centimeters.
      • Cubic Feet – The product is measured in cubic feet.
      • Cubic Inch – The product is measured in cubic inches.
      • Cylinder – The product is measured in cylinders.
      • Centimeter – The product is measured in centimeters.
      • Can – The product is measured in cans.
      • Crate – The product is measured in crates.
      • Cartridge – The product is measured in cartridges.
      • Cubic Meter – The product is measured in cubic meters.
      • Carton – The product is measured in cartons.
      • Kilometer – The product is measured in kilometers.
      • Deciliter – The product is measured in deciliters.
      • Dispenser – The product is measured in dispensers.
      • Decimeter – The product is measured in decimeters.
      • Drum – The product is measured in drums.
      • Display – The product is measured in displays.
      • Dozen – The product is measured in dozens.
      • Each – The product is measured in eaches.
      • Fluid Ounce (US) – The product is measured in US fluid ounces.
      • Gallon (US) – The product is measured in US gallons.
      • Gaylord Box – The product is measured in gaylord boxes.
      • Gram – The product is measured in grams.
      • Gram or Liter – The product is measured in grams or liters.
      • Gross – The product is measured in grosses of product.
      • Hectoliter – The product is measured in hectoliters.
      • Kiloliter – The product is measured in kiloliters.
      • Kilogram – The product is measured in kilograms.
      • Kit – The product is measured in kits.
      • Pound (US) – The product is measured in US pounds.
      • Lot – The product is measured in lots.
      • Liter – The product is measured in liters.
      • Meter – The product is measured in meters.
      • Microgram – The product is measured in micrograms.
      • Microliter – The product is measured in microliters.
      • Milligram – The product is measured in milligrams.
      • Milliliter – The product is measured in milliliters.
      • Millimeter – The product is measured in millimeters.
      • Million – The product is measured in millions.
      • Ounce – The product is measured in ounces.
      • Pack – The product is measured in packs.
      • Package – The product is measured in packages.
      • Pair – The product is measured in pairs.
      • Pallet – The product is measured in pallets.
      • Piece – The product is measured in pieces.
      • Pint – The product is measured in pints.
      • Pouch – The product is measured in pouches.
      • Quart – The product is measured in quarts.
      • Roll – The product is measured in rolls.
      • Set – The product is measured in sets.
      • Sheet – The product is measured in sheets.
      • Square Centimeter – The product is measured in square centimeters.
      • Square Foot – The product is measured in square feet.
      • Square Inch – The product is measured in square inches.
      • Square Meter – The product is measured in square meters.
      • Tablet – The product is measured in tablets.
      • Thousand Piece – The product is measured in thousand pieces.
      • Thousand – The product is measured in thousands.
      • Tote – The product is measured in totes.
      • Tray – The product is measured in trays.
      • Tube – The product is measured in tubes.
      • Unit – The product is measured in units.
      • Vial – The product is measured in vials.
  13. Select the Next icon in the top right of the screen to navigate to the next product in the recall.

    The View Product screen for Product Number 2 displays.

  14. Repeat steps 10-12 for each product in the recall.
  15. Select View Recall link above the View Product screen title for the last product in the recall.
  16. Select Submit in the top right of the View Recall [TraceLink Recall ID] screen.
  17. Select Submit in the Submit Response panel.

    The quantity and impact responses for each product in the recall are submitted to TraceLink.

Tips

  • If the impact and quantity sections have been completed for all products in the recall, users can select the Submit & Close button instead of the Submit button, to submit the completion response along with the impact and quantity responses for the location. Submitting the completion response updates the recall's Response Status for the location from In Progress to Completed. For users who belong to companies who are configured to review recall responses before submitting them to TraceLink, the recall's Response Status for the location is updated to Pending Review.

Recall coordinators or pharmacy technicians can submit the completion response for a recall on behalf of a location indicating that the impact and quantity responses for each product in recall are complete and that the recall can be closed. Submitting the completion response for a recall updates the recall's Response Status to Completed.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Click Search in the Do menu.
  5. Filter to find the recall.
  6. Select the Action icon in the row for the recall.
  7. Select View Recall.

  8. Select View Full Details in the Recall Summary panel.

  9. Select Submit.
  10. Select Submit & Close in the Submit Response panel.

    The completion response for the location is submitted and the recall's Response Status for the location is updated to Completed. For users who belong to companies who are configured to review recall responses before submitting them to TraceLink, the recall's Response Status for the location is updated to Pending Review.

Recall coordinators for a company or location can reopen a previously completed recall on behalf of a location that was marked as completed by accident or to fix an issue with the quantity or impact response for one or more products in the recall. Reopening a recall updates its Response Status from Completed to Reopened.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the recall.
  7. Select the Action icon in the row for the recall.
  8. Select View Recall.
  9. Select View Full Details in the Recall Summary panel.
  10. Select Reopen on the View Recall [TraceLink Recall ID] screen.

  11. Enter the Reason for reopening the recall in the confirmation dialog box (optional).

  12. Select Reopen.

    The recall is reopened and its Response Status is updated to Reopened. For users at companies that are configured to review recall responses before submitting them to TraceLink, the recall's Response Status for the location is updated to Pending Review.

Monitor ongoing recalls

Monitor recalls at a high level to understand the state of all recalls that you have access to. For example, recall coordinators might need to investigate the number of recalls that have been open for 15 or more days.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.

  5. Select Monitor in the Do side menu.

    View the cards in the dashboard, which display pre-defined queries to demonstrate the state of all recalls for your company or location at a high level. The labels on each card in the dashboard display a value as a link to the right. When selected, this link displays the Search Recalls screen, filtered to the selected value. For example, if the value for Not Acknowledged is selected, the Search Recalls screen displays with a filter applied to show only recalls with a Response Status of Not Acknowledged.

  6. Select the location to monitor recalls for from the Responding Entity field, or remove the current selection to monitor recalls across all locations you have access to.

    Only users assigned the Expanded Recalls Access role can monitor recalls for all locations they have access to using the Responding Entity field. For users assigned the Standard Recalls Access role, the Responding Entity field displays the location they have access to as static text.

All Recalls by Response Status card

A list of the response statuses for all ongoing recalls for the Network and Team selected in the header. A horizontal bar chart displays on this card with the following values, based on whether the user is assigned a role with expanded or standard access:

  • Not Acknowledged – The number of recalls with a Response Status of Not Acknowledged.
  • In Progress – The number of recalls with a Response Status of In Progress.
  • Pending Review – The number of recalls with a Response Status of Pending Review.
  • Completed – The number of recalls with a Response Status of Completed.
  • Reopened – The number of recalls with a Response Status of Reopened.

Open Recalls by Days Since Notification card

A summary of all recalls for the Network and Team selected in the header based on how long ago your company or location was notified about a recall without already closing that recall. A list displays on this card with the following values:

  • 2 Days or Less – The number of recalls that have not yet been closed that your company or location received the initial notification for in the last 2 days or less.
  • 3 to 7 Days – The number of recalls that have not yet been closed that your company or location received the initial notification for in the last 3 to 7 days.
  • 8 to 14 Days – The number of recalls that have not yet been closed that your company or location received the initial notification for in the last 8 to 14 days.
  • 15 Days or More – The number of recalls that have not yet been closed that your company or location received the initial notification for in the last 15 days or more.

Open Recalls by Due Date card

A summary of all open recalls for the Network and Team selected in the header based on their Due Date. A horizontal bar chart displays on this card with the following values:

  • Past Due – The number of recalls that have not yet been closed with a due date prior to the current date.
  • This Week – The number of recalls that have not yet been closed and are due within the next 7 days.
  • Next Week – The number of recalls that have not yet been closed and are due in the next 7 to 14 days.
  • In 2 or More Weeks – The number of recalls that have not yet been closed and are due in more than 14 days.

Open Recalls by Classification card

A summary of all open recalls for the Network and Team selected in the header based on their Classification. A horizontal bar chart displays on this card with the following values:

  • Class 1 – The number of recalls with a Classification of Class 1.
  • Class 2 – The number of recalls with a Classification of Class 2.
  • Class 3 – The number of recalls with a Classification of Class 3.
  • Not Yet Classified – The number of recalls with a Classification of Not Yet Classified.

Open Recalls by Product Type card

A summary of all open recalls for the Network and Team selected in the header based on their Product Type. A horizontal bar chart displays on this card with the following values:

  • Biologics – The number of recalls with a Product Type of Biologics.
  • Devices – The number of recalls with a Product Type of Devices.
  • Drugs – The number of recalls with a Product Type of Drugs.
  • Veterinary – The number of recalls with a Product Type of Veterinary.

Search for a specific recall at a specific location.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.

  5. Select Search from the side menu.

  6. Fill in one or more of the following fields to filter the results:
    • Last Activity field – The period of time in which the recall was last updated by the responding location:
      • Last Week – The recall was updated in the last 7 days.
      • Last Month – The recall was updated in the last 30 days.
      • Last 3 Months – The recall was updated in the last 92 days.
      • Last 6 Months – The recall was updated in the last 184 days.
      • Custom Range – Select a specific period of time that the recall was updated in from the calendar.

    • Response Status drop-down – The status of the recall for a location.

      • Not Acknowledged – No action has been taken on the recall.
      • In Progress – The recall is acknowledged and impact and quantity responses for individual products in the recall might be submitted.
      • Completed – All recall responses (acknowledgment, impact, quantity, and completion) are submitted and any impacted product on hand is returned to the recalling company.
      • Reopened – The recall is reopened after previously having a Response Status of Completed.
      • Opted Out – The location is not impacted by any products in the recall.
    • Responding Entity field – The name and identifier of the internal or Partner location responding to the recall.
      • Only users assigned the Expanded Recalls Access Role can filter responses using the Responding Entity field. For users assigned the Standard Recalls Access Role, the Responding Entity field displays the location they have access to as static text.

  7. Select Show Additional Filters and fill in one or more of the following fields to further filter the results:

    • Date Published field – The period of time in which the recall was published by the FDA:
      • Last Week – The recall was published in the last 7 days.
      • Last Month – The recall was published in the last 30 days.
      • Last 3 Months – The recall was published in the last 92 days.
      • Last 6 Months – The recall was published in the last 184 days.
      • Custom Range – Select a specific period of time that the recall was published in from the calendar.
    • TraceLink Recall ID field – The unique identifier that TraceLink assigned to the recall.
    • FDA Event ID field – The unique identifier that the FDA assigned to the recall.
    • FDA Recall Number field – The unique identifier that the FDA assigns to each product the recall.

    • Recall Class drop-down – The degree of health hazard presented by one or more products in the recall:

      • Class 1 – There is a reasonable probability that the use of, or exposure to, the affected product will cause serious adverse health consequences or death.
      • Class 2 – The use of, or exposure to, the affected product may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.
      • Class 3 – The use of, or exposure to, the affected product is not likely to cause adverse health consequences.
      • Not Yet Classified – The degree of health hazard that the recall presents has not been determined yet.
    • Reason for Recall field – The reason that the recalling company recalled the product.
    • Product Description field – Details about the recalled product (e.g. name and dosage).
    • Recalling Company field – The name and address of the company that manufactured the recalled product.
    • Assigned to User field – The name of the user from the responding entity that is assigned to the recall.
    • Code Information Type drop-down – The type of unique information associated with the products in the recall:
      • Biologics Product Code – The recall contains one or more products identified with a biologics product code.
      • Expiration Date – The recall contains one or more products with an expiration date.
      • Expiration Date Range – The recall contains one or more products with an expiration date range.
      • GTIN – The recall contains one or more products with a GTIN.
      • List – The recall contains one or more products with a product name, sequencing number, prescription or over the counter use indication, or dosage form.
      • Lot Number – The recall contains one or more products with a lot number.
      • Material Number – The recall contains one or more products with a material number.
      • Model Number – The recall contains one or more products with a model number.
      • NDC – The recall contains one or more products with an NDC.
      • Part Number – The recall contains one or more products with a part number.
      • Product Code – The recall contains one or more products with a product code.
      • Product Catalog Number – The recall contains one or more products with a product catalog number.
      • Reference Number – The recall contains one or more products with a reference number.
      • Serial Number – The recall contains one or more products with a serial number.
      • Serial Number Range – The recall contains one or more products with a serial number range.
      • UDI – The recall contains one or more products identified with a Unique Device Identifier (UDI).
      • UPC – The recall contains one or more products identified with a Universal Product Code (UPC).
    • Code Information Value field– The value for the unique information associated with the products in the recall.
    • Notification Level drop-down – The furthest level down the supply chain that must be notified of the recall:
      • Consumer Level – The people who purchase or use the product must be notified.
      • Retail Level – The companies that people purchase or receive the product from must be notified.
      • Wholesale Level – The companies that are involved in the distribution of the product to retail locations must be notified.
    • FDA Recall Status drop-down – The state of the recall according to the FDA:
      • Ongoing – Notification to impacted stakeholders and removal of the affected product from the supply chain is being completed.
      • Completed – All impacted stakeholders have been notified of the recall and the affected product has been removed from the supply chain.
      • Terminated – All reasonable efforts have been made to remove the affected product from the supply chain.
  8. Select Apply.

    The filtered results display in the table.

Download a CSV file with a list of recalls displayed in the results table.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.

  5. Select Search from the side menu.

  6. Filter to find the list of recalls to download.

  7. Select the Download icon in the top right of the screen.

    The CSV downloads with the recalls from the table.

Recall coordinators and pharmacy technicians can view the details of a location's recall response submitted to TraceLink to ensure the accuracy of the response, reference the response details, or investigate any discrepancies related to the response.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the recall.
  7. Select the Action icon in the row for the recall.
  8. Select View Responses.
  9. Fill in one or more of the following fields to filter the results on the View Responses screen:
    • Responding Entity field – The name and identifier of the internal or Partner location responding to the recall.
      • Only users assigned the Expanded Recalls Access Role can filter responses using the Responding Entity field. For users assigned the Standard Recalls Access Role, the Responding Entity field displays the location they have access to as static text.

    • Response Type drop-down – The type of recall response submitted to TraceLink:

      • Acknowledgment – Confirmation that the responding location has been informed of the recall and the individual products being recalled.
      • Impact – Communicates whether each product being recalled is in stock at the location.
      • Quantity – Communicates how much of each product type (e.g. 60 count bottles) in the recall are in stock at the location.
      • Completion – Confirms that the impact and quantity responses for each product in the recall are completed.
    • Date Submitted field – The period of time in which the response was submitted to Tracelink:
      • Last Week – The response was submitted in the last 7 days.
      • Last Month – The response was submitted in the last 30 days.
      • Last 3 Months – The response was submitted in the last 92 days.
      • Last 6 Months – The response was submitted in the last 184 days.
      • Custom Range – Select a specific period of time that the recall response was submitted in from the calendar.
  10. Select Apply.

    The filtered results display in the table.

  11. Select the View icon in the row for the response.

    The View [Response Type] Response screen displays with details about the response.

Recall coordinators and pharmacy technicians can download a recall's responses in CSV format and send them to the recalling company to comply with FDA effectiveness reporting requirements or store them for record keeping purposes.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the recall.
  7. Select the Action icon in the row for the recall.
  8. Select View Responses.
  9. Fill in one or more of the following fields to filter the results on the View Responses screen:
    • Responding Entity field – The name and identifier of the internal or Partner location responding to the recall.
      • Only users assigned the Expanded Recalls Access Role can filter responses using the Responding Entity field. For users assigned the Standard Recalls Access Role, the Responding Entity field displays the location they have access to as static text.

    • Response Type drop-down – The type of recall response submitted to TraceLink:

      • Acknowledgment – Confirmation that the responding location has been informed of the recall and the individual products being recalled.
      • Impact – Communicates whether each product being recalled is in stock at the location.
      • Quantity – Communicates how much of each product type (e.g. 60 count bottles) in the recall are in stock at the location.
      • Completion – Confirms that the impact and quantity responses for each product in the recall are completed.
    • Date Submitted field – The period of time in which the response was submitted to Tracelink:
      • Last Week – The response was submitted in the last 7 days.
      • Last Month – The response was submitted in the last 30 days.
      • Last 3 Months – The response was submitted in the last 92 days.
      • Last 6 Months – The response was submitted in the last 184 days.
      • Custom Range – Select a specific period of time that the recall response was submitted in from the calendar.
  10. Select Apply.

    The filtered results display in the table.

  11. Select the Download icon in the top right of the screen.

    The filtered results are downloaded as a CSV file.

View updates made to the recall by the FDA or the recalling company by comparing two versions of the recall. Comparing two versions of the recall allows recall coordinators to quickly view only the attributes that have been updated from one version to the next.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the recall.
  7. Select the Action icon in the row for the recall.
  8. Select View Recall.

  9. Select View Full Details in the Recall Summary panel.

  10. Select the Action icon in the top right of the screen.
  11. Select View Recall Updates.
  12. On the View Recall Updates screen, select the checkbox in the row for 2 Versions to see the values that have changed from one version to the next.
  13. Select Compare Versions in the top right of the screen.

    The Compare Versions screen displays with all of the recall attributes that have been updated from one version to the next.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the recall.
  7. Select the Action icon in the row for the recall.

  8. Select View Response Activity.

    View the previous actions taken on the recall, as well as who took the action and when.

Tips

  • A location's recall response activity can also be accessed from the View Recall [TraceLink Recall ID] screen using the Action icon in the top right of the screen.
In this release, following a recall only records that user as a follow of the recall. In a future release, following a recall will enables users to receive notifications about the recall.
  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the recall.
  7. Select the Action icon in the row for the recall.
  8. Select View Recall.

  9. Select View Full Details in the Recall Summary panel.

  10. Select the Action icon in the top right of the screen.

  11. Select Follow or Unfollow.

    If you are currently not  following the recall, you begin following the recall. If you are currently following the recall, you stop following the recall.

Tips

  • A recall can also be followed or unfollowed from the View Response Activity screen using the Action icon in the top right of the screen.

Track recalls

Recall coordinators can view high-level information about a recall and track the overall response status for all of their locations and send follow up messages to locations with the same response status. Viewing high-level information about the recall and which locations are in which state of the recall (e.g. not acknowledged) enables recall coordinators to quickly understand the overall progress made by their company towards completing and closing the recall without having to dig into the locations individually to view the status of each response.

Recall coordinators can view high-level information about a recall and track the overall response status for all of their locations to quickly understand the overall progress made by their company towards completing and closing the recall.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.

  5. Select Track in the Do side menu.

  6. Enter the recall's TraceLink Recall ID or FDA Event ID on the Track Recall Progress screen.

    The high-level details and response status for each location and Partner company display for the recall.

Recall coordinators can send follow up messages to locations with the same response status for a given recall to communicate with or quickly remind locations of deadlines that have past or are approaching.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.

  5. Select Track in the Do side menu.

  6. Enter the recall's TraceLink Recall ID or FDA Event ID on the Track Recall Progress screen.

    The high-level details and response status for each location and Partner company display for the recall.

  7. Select the Message icon in the row for the response status you want to send a message about.

  8. In the Send Message panel:

    1. Enter the Message to send to responding entities.
    2. Unselect any Responding Entities that should not receive the message.
    3. Select Send.

      The message is sent to all users at the selected responding entities both as an email and a notification in the Agile Process Teams solution.

Approve recall responses

Recall coordinators can approve or reject a recall's responses that were submitted on behalf a location. Approving or rejecting a location's recall responses enables companies and recall coordinators to ensure their locations' responses are accurate and all products are accounted for by checking the responses for inconsistencies and discrepancies. Additionally, recall coordinators can also approve when a recall is reopened.

Only users who are assigned the Expanded Recalls Access role at companies whose Recalls instance is configured to review responses submitted by locations before submitting them to TraceLink can review and approve recall responses.
  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Recalls Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the recall.
  7. Select the Action icon in the row for the recall.
  8. Select View Recall.

  9. Select View Full Details in the Recall Summary panel.

  10. Select Approve.

    The recall's responses are submitted to TraceLink and its Response Status is updated from Pending Review to Completed. If the recall is being reopend, its Response Status is updated from Completed to Reopened.

Tips

  • To reject a recall's responses, select Reject in the top right of the View Recall [Recall ID] screen and enter the Reason for rejecting the recall's response in the confirmation dialog box.