BEUDAMED
    FDA Recall Open, Classified

    Access Thyroglobulin Calibrators

    Recall: Z-0100-2024 · Initiated July 6, 2023

    Recall

    Recall Number
    Z-0100-2024
    Event Number
    92670
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    MSW
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    July 6, 2023
    Posted
    October 11, 2023
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    Description

    Access Thyroglobulin Calibrators

    Reason

    It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.

    Action

    Beckman Coulter issued an Urgent Medical Device Recall letter dated 06/28/2023 to its consignees affected worldwide on 07/06/2023 via email or letter and followed with an updated letter (dated 07/07/2023) issued on 07/14/2023 which contained FDA suggested edits. The notice explained the problem, the risk to the patient and requested the following actions be taken: If you have downloaded the alternative calibrator card issued in April 2023, please discard that calibrator card, and do not use it moving forward. . Only use Access Thyroglobulin calibrator lots 338013 or higher to calibrate Access Thyg reagent packs (C71762), when this becomes available in your laboratory. . Continue to use any lot of Thyroglobulin Calibrator (PN 33865) with Access Thyroglobulin Reagent packs (33860). The firm issued an Important Product Notification letter was issued on 2023 August 10 notifying customers in the US, Canada, and China that they were NOT affect by this issue and to disregard the prior Urgent Medical Device Recall letters.

    Distribution

    worldwide except US, Canada, and China

    Quantity

    5980 units