BEUDAMED
    FDA Enforcement Class II 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 · Reported March 16, 2016

    Enforcement

    Recall Number
    Z-1090-2016
    Event ID
    73357
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TEM Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 16, 2016
    Initiation Date
    February 18, 2016
    Classification Date
    March 9, 2016
    Termination Date
    June 30, 2016
    Address
    3210 E Nc Hwy 54, N/A, Durham, NC, 27709, United States

    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.

    Code Info

    Lot 41925401

    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