BEUDAMED
    FDA Enforcement Class II Terminated

    ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a 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.

    Recall: Z-1744-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1744-2018
    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 IgGAM; REF Number: RK040D; UDI: 03663537018770 a 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.

    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, F1600568P2, F1700415P1, F1700415P2, F1701369P1, F1701369P2

    Distribution

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

    Quantity

    281