BEUDAMED
    FDA Recall Terminated

    ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.

    Recall: Z-1090-2016 · Initiated February 18, 2016

    Recall

    Recall Number
    Z-1090-2016
    Event Number
    73357
    Firm
    TEM Systems Inc
    FEI Number
    3008366794
    Product Code
    GGN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 18, 2016
    Terminated
    June 30, 2016
    Address
    3210 E Nc Hwy 54, Durham, NC, 27709

    Description

    ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.

    Reason

    Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016.

    Action

    An Urgent Important Customer Information notice was sent to accounts on 2/17/2016. The notice requested that they discontinue use of the product and to contact them for a replacement. The letter also included a response form to be returned.

    Distribution

    Distributed in the states of AZ, AR, CA, FL, GA, HI, ID, IL, IN, LA, MD, MA, MN, MO, NE, NJ, NM, NY, PA, OH, SC, SD, TN, TX, UT, WA, WV and the country of Germany.

    Quantity

    476 boxes x 5 vials