BEUDAMED
    FDA Enforcement Class II Ongoing

    Access Total T4, REF 33800, IVD, thyroxine reagent assay.

    Recall: Z-1303-2024 · Reported March 27, 2024

    Enforcement

    Recall Number
    Z-1303-2024
    Event ID
    94012
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2024
    Initiation Date
    February 8, 2024
    Classification Date
    March 15, 2024
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037, United States

    Description

    Access Total T4, REF 33800, IVD, thyroxine reagent assay.

    Reason

    Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.

    Code Info

    Lot numbers: 338555, exp. 31 JUL 2024; 338556, exp. 31 AUG 2024; 338734, exp. 30 SEP 2024; and 338958, exp. 31 OCT 2024; UDI-DI 15099590225742.

    Distribution

    Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Bahrain, Bangladesh, Bolivia, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Egypt, El Salvador, Georgia, Greece, Hong Kong, India, Kazakhstan, Mexico, Namibia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Taiwan, Thailand, Turkey, U.A.E, Vietnam, and Zimbabwe.

    Quantity

    64,009 kits