Haemonetics Corporation recalls Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for…

Recall date

January 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1130-2015

FDA classification

Class II

Brand / firm

Haemonetics Corporation

Sold / distributed

Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.