BEUDAMED
    FDA Enforcement Class II 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 · Reported November 2, 2016

    Enforcement

    Recall Number
    Z-0302-2017
    Event ID
    75265
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TEM Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 2, 2016
    Initiation Date
    September 13, 2016
    Classification Date
    October 23, 2016
    Termination Date
    December 5, 2017
    Address
    3210 E Nc Hwy 54, Durham, NC, 27709, United States

    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.

    Code Info

    Lot No. 21929007

    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