BEUDAMED
    FDA Recall Terminated

    ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    Recall: Z-0620-2019 · Initiated November 1, 2018

    Recall

    Recall Number
    Z-0620-2019
    Event Number
    81488
    Firm
    Clark Laboratories, Inc. (dba, Trinity Biotech USA)
    FEI Number
    1318354
    Product Code
    GKA
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    November 1, 2018
    Terminated
    June 21, 2022
    Address
    2823 Girts Rd, Jamestown, NY, 14701-9666

    Description

    ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    Reason

    lack of 510K

    Action

    The firm initiated the recall by letter on 11/01/2018. The letter explained the problem and requested the return of the recalled items.

    Distribution

    IL, WV, NJ, AZ, MD, UT

    Quantity

    14 devices