BEUDAMED
    FDA Enforcement Class II Terminated

    ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810

    Recall: Z-1743-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1743-2018
    Event ID
    79797
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hyphen BioMed
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 16, 2018
    Initiation Date
    February 5, 2018
    Classification Date
    May 8, 2018
    Termination Date
    August 16, 2018
    Address
    155 rue d Eragny, N/A, Neuville Sur Oise, N/A, N/A, France

    Description

    ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810

    Reason

    Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.

    Code Info

    Lot numbers: F1600568P1, F1701370P1, F1701370P2

    Distribution

    OH, MD, NC, NY, NH, Canada, Sweden

    Quantity

    60