FDASeptember 13, 2016device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Customers complained of low/empty reagent vials.
What to do
FDA enforcement status: Terminated
Brands named
tem systemstem
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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