Reported Feb 25, 2015 · Terminated
Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for…
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 Rd · Braintree, MA · 02184-2412
Is this the product you have?
- Haemonetics TEG Hemostasis System Level II Control
- Catalog number8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System
- Lot codes and dates
- Lot numbersHMO 9200 HMO 9217 HMO 9226 HMO 9232 HMO 9276 HMO 9285 HMO 9292 Exp. Date 1/2017
- Amount recalled
- 4,143 kits
Why it was recalled
Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.
This product could cause temporary or reversible health problems — stop using it.
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