BEUDAMED
    FDA Enforcement Class II Ongoing

    Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

    Recall: Z-3305-2024 · Reported October 9, 2024

    Enforcement

    Recall Number
    Z-3305-2024
    Event ID
    95259
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2024
    Initiation Date
    August 21, 2024
    Classification Date
    September 27, 2024
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

    Reason

    Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.

    Code Info

    UDI-DI: Material Number 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942; Lot Number: 26098336 26099336

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    9783 kits