BEUDAMED
    FDA Recall Open, Classified

    HemosIL ReadiPlasTin, Part No. 0020301400

    Recall: Z-1052-2022 · Initiated April 8, 2022

    Recall

    Recall Number
    Z-1052-2022
    Event Number
    90012
    Firm
    Instrumentation Laboratory
    FEI Number
    1217183
    Product Code
    GJS
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 8, 2022
    Address
    180 Hartwell Rd, Bedford, MA, 01730-2443

    Description

    HemosIL ReadiPlasTin, Part No. 0020301400

    Reason

    Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.

    Action

    On April 8, 2022, the firm notified customers via email and certified mail. Customers were informed that the firm will stop shipment of product on May 9, 2022. After receipt of the material, customers must complete the conversion to HemosIL RecombiPlasTin 2G, with support as needed from your local Werfen representative, within 90 days. Until a lot of HemosIL RecombiPlasTin 2G has been received and ready for use, customers should run quality control for HemosIL ReadiPlasTin with each new reagent vial (every lot) and at least every 8 hours to identify vials with performance issues. Any product with failed quality control or quality control results which trend high should be discarded. Once customers have completed the comversion to HemosIL RecombiPlasTin 2G, any remaining unused HemosIL ReadiPlasTin should be destroyed.

    Distribution

    US Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS, MD, ME, MI, MN, MO, NC, NE, NY, OH, OK, SC, TX, VA, WV.

    Quantity

    1,563 (US); 29,046 (OUS)