Reported Nov 2, 2016 · Terminated
ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation…
TEM Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TEM Systems Inc · 3210 E Nc Hwy 54 · Durham, NC · 27709
Is this the product you have?
- 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.
- Lot codes and dates
- Lot No. 21929007
- Amount recalled
- 637 boxes x 10 vials
Where it was sold
Why it was recalled
Customers complained of low/empty reagent vials.
This product could cause temporary or reversible health problems — stop using it.
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