BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2782-2016 · Initiated July 11, 2016

    Recall

    Recall Number
    Z-2782-2016
    Event Number
    74932
    Firm
    Clark Laboratories, Inc. (dba, Trinity Biotech USA)
    FEI Number
    1318354
    Product Code
    PCL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 11, 2016
    Posted
    September 12, 2016
    Terminated
    May 9, 2017
    Address
    2823 Girts Rd, Jamestown, NY, 14701-9666

    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).

    Action

    Recall notification letters (dated 7/11/2016) were sent by FedEx on 7/11/2016. Customers were instructed to discontinue use of any remaining inventory (discard on site if any remaining). Customers were also advised that if the test resulted in a valid run, such that all Controls and Calibrator met the Quality Control Criteria as stated in the package insert, the patient results can be reported and a re-evaluation of patient results is not necessary. For questions, please contact Trinity Biotech's Help Desk at 1-800-325-3424 Option #3.

    Distribution

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

    Quantity

    US: 6 kits, Foreign: 50 kits