BEUDAMED
    FDA Enforcement Class II 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 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-1062-2018
    Event ID
    79269
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hyphen BioMed
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 21, 2018
    Initiation Date
    November 9, 2011
    Classification Date
    March 15, 2018
    Termination Date
    June 21, 2018
    Address
    155 rue d Eragny, Neuville Sur Oise, N/A, France

    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.

    Code Info

    UDI: 03663537018770 Lot Number: F1700415

    Distribution

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

    Quantity

    94