BEUDAMED
    FDA Recall Terminated

    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

    Recall: Z-2650-2014 · Initiated July 18, 2014

    Recall

    Recall Number
    Z-2650-2014
    Event Number
    69070
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    KFF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 18, 2014
    Posted
    September 16, 2014
    Terminated
    January 16, 2015
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

    Reason

    Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.

    Action

    Diagnostica Stago sent a "Quality Information" letter/Customer Acknowledgement form to its customers. The letter identified the product, problem, and actions to be taken by the customers. For additional information and further support contact the Diagnostica Stago Hotline at 800-725-0607.

    Distribution

    Distributed USA (nationwide) and the country of Canada.

    Quantity

    514 kits