FDA-Device2015-02-25Class II
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.
Haemonetics Corporation
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.
Sold states
Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
Affected count
4,143 kits
Manufactured in
400 Wood Rd, Braintree, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1130-2015Don't want to check this manually?
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