BEUDAMED
    FDA Enforcement Class II Ongoing

    Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.

    Recall: Z-1084-2026 · Reported January 21, 2026

    Enforcement

    Recall Number
    Z-1084-2026
    Event ID
    98163
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Diagnostica Stago, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 21, 2026
    Initiation Date
    December 15, 2025
    Classification Date
    January 14, 2026
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607, United States

    Description

    Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.

    Reason

    Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.

    Code Info

    Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, HI, IA, MA, MI, NJ, NV, NY, OH, TN, WI and the countries of Belgium, Canada, Denmark, Algeria, Spain, Finland, France, Great Britain, Italy, Lebanon, Saudi Arabia, Uganda.

    Quantity

    438 units