Reported Jul 31, 2013 · Terminated
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Haemonetics Corporation
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: Haemonetics Corporation · 400 Wood Road · Braintree, MA · 02184-2412
Is this the product you have?
- TEG 5000 Thromboelastograph
- Coagulation Analyzer Product UsageMultipurpose System for In Vitro Coagulation Studies
- Lot codes and dates
- Per recall strategy.
- Amount recalled
- 1590 devices
Where it was sold
- Nationwide
Why it was recalled
Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
This product could cause temporary or reversible health problems — stop using it.
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