BEUDAMED
    FDA Recall Terminated

    PREMIER EHEC and PREMIER EHEC Bulk.

    Recall: Z-1033-2017 · Initiated November 8, 2016

    Recall

    Recall Number
    Z-1033-2017
    Event Number
    75651
    Firm
    Meridian Bioscience Inc
    FEI Number
    1524213
    Product Code
    GNA
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 8, 2016
    Posted
    January 17, 2017
    Terminated
    August 16, 2017
    Address
    3471 River Hills Dr, Cincinnati, OH, 45244-3023

    Description

    PREMIER EHEC and PREMIER EHEC Bulk.

    Reason

    Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.

    Action

    On November 7, 2016 the firm sent Voluntary Medical Device Recall Letters and reply forms to their customers.

    Distribution

    Product was shipped to the following states: AL. AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY. Product was also sent to the following countries: CANADA, GERMANY, HONG KONG, ITALY, JAPAN & NEW ZEALAND.

    Quantity

    4,747 EHEC + 180 EHEC Bulk