Device Recall Pointe Scientific Glucose Oxidase Reagent

All lots beginning in 722601, Exp. 08/09. (Lots 722601, 722601-009, 722601-017, 722601-035, 722601-057, 722601-072, 722601-081, 722601-084, 722601-085, 722601-092, 722601-093, 722601-094, 722601-134, 722601-136, 722601-168, 722601-185, 722601-232, 722601-233, 722601-254, 722601-255, 722601-318, 722601-337, and 722601-361.)

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- USA, Hong Kong, Indonesia, Israel, Jordan, Mexico, Nigeria, Poland, Russia, Serbia, Sri Lanka, Trinidad, and Venezuela.

Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Reagent Set, 2MM Corporation, Miami, FL; Reorder # RT-160-500. Pointe Scientific Glucose Oxidase Reagent, Pointe Scientific, Inc., Canton, MI; Catalog, MI; Catalog # 2-G7519-L, 7-G7519-100, 7-G7519-200, 7-G7519-1000, 8-G7519-100, and 12-RT-160-500. || For the quantitative determination of Glucose in human serum. For in vitro diagnostic use only.