BEUDAMED
    FDA Recall Terminated

    ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.

    Recall: Z-0302-2017 · Initiated September 13, 2016

    Recall

    Recall Number
    Z-0302-2017
    Event Number
    75265
    Firm
    TEM Systems Inc
    FEI Number
    3008366794
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 13, 2016
    Terminated
    December 5, 2017
    Address
    3210 E Nc Hwy 54, Durham, NC, 27709

    Description

    ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.

    Reason

    Customers complained of low/empty reagent vials.

    Action

    Customers were notified of the recall by an Urgent Important Customer Information letter on 9/13/2016. The letter described the device and the problem. Customers were told to stop using the product and to call for replacement product. The letter included a Confirmation of Compliance Letter which was to be completed and returned.

    Distribution

    Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV.

    Quantity

    637 boxes x 10 vials