BEUDAMED
    FDA Enforcement Class III Terminated

    Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.

    Recall: Z-0819-2015 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0819-2015
    Event ID
    69827
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clark Laboratories, Inc. (dba,Trinity Biotech USA)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 24, 2014
    Initiation Date
    November 17, 2014
    Classification Date
    December 16, 2014
    Termination Date
    May 24, 2016
    Address
    2823 Girts Rd, N/A, Jamestown, NY, 14701-9666, United States

    Description

    Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.

    Reason

    Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.

    Code Info

    Lot 033, expiry date 30 November 2014

    Distribution

    New York, Florida, Utah, and California plus foreign distribution to Spain and France

    Quantity

    Domestic: 9 kits; Foreign: 26 kits