BEUDAMED
    FDA Recall 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 · Initiated February 5, 2018

    Recall

    Recall Number
    Z-1742-2018
    Event Number
    79797
    Firm
    Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France
    FEI Number
    3004434070
    Product Code
    LCO
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 5, 2018
    Terminated
    August 16, 2018

    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.

    Action

    On March 6, 3018 Aniara Diagnostica began emailing Urgent Medical Device Recall notifications to affected customers. Customers are instructed to: Use the US Instructions for Use and Return the completed Acknowledgement Awareness Form. Customers with questions may contact Aniara Diagnostica via e-mail at [email protected] or by phone at (866)783-3797 ext. 110.

    Distribution

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

    Quantity

    12