BEUDAMED
    FDA Recall Open, Classified

    Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860

    Recall: Z-2322-2025 · Initiated July 10, 2025

    Recall

    Recall Number
    Z-2322-2025
    Event Number
    97255
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    MSW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 10, 2025
    Posted
    August 13, 2025
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    Description

    Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860

    Reason

    Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.

    Action

    An URGENT MEDICAL DEVICE RECALL notification dated 7/2/25 was sent to customers. ACTION: " Discontinue using Access Thyroglobulin reagent lot 439163 and discard all remaining reagent packs from this lot. " At the discretion of the medical director, a retrospective review of patient results generated with Access Thyroglobulin reagent lot 439163 should be performed, which includes reviewing patient history, to assess the need for retesting. " Please contact your local Beckman Coulter representative for replacement product requests and to receive updates on availability and delivery. RESOLUTION: Beckman Coulter is investigating the root cause of this issue to prevent similar occurrences. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center: " From our website: http://www.beckmancoulter.com " Contact your local Beckman Coulter Representative for replacement.

    Distribution

    Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain.

    Quantity

    453 units