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Haemonetics Corporation recalls Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control f
Recalled February 25, 2015 · FDA recall Z-1130-2015 · Haemonetics
Hazard
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. · FDA Class II
Units
4,143 kits
Sold at
Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
Description
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.
Product
Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.
Manufacturer(s)
Haemonetics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →