Device Recall GEM Check Coag Whole Blood Controls

Part Number 06260061600; Lot C9GC5001, Exp. 7/31/2010; G9GC5003, Exp 1/31/2011; J9GC5004, Exp 3/31/2011; and C0GC5001, Exp 10/31/2011.

Hematology and Pathology Devices

2

No

Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.

GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: || IVD. 15/pk. 06260061600. || Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125. || Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.