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Recall Observatory FDA recall evidence

Device product

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.

Z-0302-2017

September 13, 2016

Class II

Product summary

Firm
TEM Systems Inc
Event
Event 75265
Status
Terminated
Classification
Class II
Quantity
637 boxes x 10 vials
Official record key
device-enforcement:Z-0302-2017

Official wording

Reason: Customers complained of low/empty reagent vials.

Code information: Lot No. 21929007

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Customers complained of low/empty reagent vials.