BEUDAMED
    FDA Recall Terminated

    ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.

    Recall: Z-1062-2018 · Initiated November 9, 2011

    Recall

    Recall Number
    Z-1062-2018
    Event Number
    79269
    Firm
    Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France
    FEI Number
    3004434070
    Product Code
    LCO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 9, 2011
    Posted
    March 15, 2018
    Terminated
    June 21, 2018

    Description

    ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.

    Reason

    A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.

    Action

    The manufacturer, HYPHEN BioMed, initiated a voluntary recall of the two lots via email. Distributors and end users are being notified and instructed to: 1) acknowledge receipt and understanding of notification, and 2) destroy affected products remaining in stock. For further questions, please call (513) 770-1993.

    Distribution

    Worldwide Distribution - US Distribution and to the countries of : Austria and France.

    Quantity

    94