BEUDAMED
    FDA Enforcement Class II Ongoing

    Access Thyroglobulin Calibrators

    Recall: Z-0100-2024 · Reported October 18, 2023

    Enforcement

    Recall Number
    Z-0100-2024
    Event ID
    92670
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 18, 2023
    Initiation Date
    July 6, 2023
    Classification Date
    October 11, 2023
    Address
    1000 Lake Hazeltine Dr, N/A, Chaska, MN, 55318-1037, United States

    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.

    Code Info

    UDI/DI 15099590227166, Serial/Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, 337940

    Distribution

    worldwide except US, Canada, and China

    Quantity

    5980 units