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TEM Systems Inc: Medical Device Recalls in 2016

Updated on March 25, 2026.

According to to data from the FDA, there were 2 medical device recalls made by TEM Systems Inc in 2016. See the details of the recalls below.

You can see similar recalls for other firms.

Data Source: FDA.
See this for other years:
2015
2016
  • 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.
  • 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.
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