BEUDAMED
    FDA Enforcement Class III Terminated

    Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

    Recall: Z-2782-2016 · Reported September 21, 2016

    Enforcement

    Recall Number
    Z-2782-2016
    Event ID
    74932
    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
    September 21, 2016
    Initiation Date
    July 11, 2016
    Classification Date
    September 12, 2016
    Termination Date
    May 9, 2017
    Address
    2823 Girts Rd, N/A, Jamestown, NY, 14701-9666, United States

    Description

    Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

    Reason

    The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).

    Code Info

    Lot Number 2326060-043, Expiration Date 31 May 2017

    Distribution

    Distribution to US nationwide including California, and China (Hong Kong).

    Quantity

    US: 6 kits, Foreign: 50 kits