BEUDAMED
    FDA Enforcement Class II Terminated

    Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.

    Recall: Z-0572-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0572-2014
    Event ID
    66916
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clark Laboratories, Inc. (dba,Trinity Biotech USA)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2014
    Initiation Date
    August 27, 2013
    Classification Date
    December 26, 2013
    Termination Date
    May 24, 2016
    Address
    2823 Girts Road, N/A, Jamestown, NY, 14701, United States

    Description

    Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.

    Reason

    Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.

    Code Info

    Product Code: 800-960, Lot number: 082, Model: 10 - plate kit

    Distribution

    USA Nationwide Distribution in the state of WA

    Quantity

    38 kits