BEUDAMED
    FDA Recall Terminated

    Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.

    Recall: Z-2445-2012 · Initiated May 29, 2012

    Recall

    Recall Number
    Z-2445-2012
    Event Number
    62440
    Firm
    Clark Laboratories, Inc. (dba, Trinity Biotech USA)
    FEI Number
    1318354
    Product Code
    GQX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 29, 2012
    Posted
    September 24, 2012
    Terminated
    May 24, 2016
    Address
    2823 Girts Road, Jamestown, NY, 14701

    Description

    Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.

    Reason

    The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.

    Action

    Trinity Biotech sent a "PRODUCT RECALL LETTER" dated May 29, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Product Recall Fax Back Form was included in the letter for customers to complete and return via fax to (716) 488-1990. Customers were instructed to discard any of the affected product. Contact the Trinity Biotech Help Desk at 800-325-3424, option 2 for questions regarding this recall.

    Distribution

    Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.

    Quantity

    810 kits