BEUDAMED
    FDA Recall Terminated

    Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma.

    Recall: Z-2243-2010 · Initiated July 15, 2010

    Recall

    Recall Number
    Z-2243-2010
    Event Number
    56291
    Firm
    BioCheck Inc
    FEI Number
    3002564473
    Product Code
    NUK
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    July 15, 2010
    Posted
    August 20, 2010
    Terminated
    December 13, 2010
    Address
    323 Vintage Park Dr, Foster City, CA, 94404-1186

    Description

    Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma.

    Reason

    Products were marketed without 510(k) for diagnostic use. Unapproved device.

    Action

    BioCheck sent an "Urgent Device Recall" letter dated July 15, 2010 to consignees identifying the products as unapproved and requesting prompt return to the firm. Consignees are asked to sub-recall. The letter requested a reponse form be completed and returned to the firm. Diagnostic claims have been removed from the website. Returned product will be quarantined by the firm pending determination of marketing status and labeling revision.

    Distribution

    Worldwide Distribution - USA, including the states of CA, MI, NJ, and PA and countries of Canada, India, S. Korea, and UAE.

    Quantity

    187 kits