BEUDAMED
    FDA Enforcement Class III 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 · Reported October 3, 2012

    Enforcement

    Recall Number
    Z-2445-2012
    Event ID
    62440
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clark Laboratories, Inc. (dba,Trinity Biotech USA)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 3, 2012
    Initiation Date
    May 29, 2012
    Classification Date
    September 24, 2012
    Termination Date
    May 24, 2016
    Address
    2823 Girts Road, N/A, Jamestown, NY, 14701, United States

    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.

    Code Info

    Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568

    Distribution

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

    Quantity

    810 kits