BEUDAMED
    FDA Enforcement Class II Terminated

    ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.

    Recall: Z-1742-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1742-2018
    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 MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.

    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: F1701084P2 and F1701084P3

    Distribution

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

    Quantity

    12