BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated December 15, 2025

    Recall

    Recall Number
    Z-1084-2026
    Event Number
    98163
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    LCO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 15, 2025
    Posted
    January 14, 2026
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    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.

    Action

    Diagnostica Stago notified consignees of the recall on about 12/15/2025 via email. Consignees were instructed to stop using Lot 271288 and dispose of all remaining product according to local regulations, and complete, sign, and return the attached Acknowledgement Form provided. Additionally, consignees were instructed that if they have distributed the affected lot to any other laboratory, please notify those recipients of this recall and ask them to complete and return an Acknowledgement Form.

    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