Devices

Device Recall Pointe Scientific Glucose Oxidase Reagent

Model / Serial
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.)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Hong Kong, Indonesia, Israel, Jordan, Mexico, Nigeria, Poland, Russia, Serbia, Sri Lanka, Trinidad, and Venezuela.
Product Description
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.
Manufacturer
Pointe Scientific, Inc.
1 Event
- Recall of Device Recall Pointe Scientific Glucose Oxidase Reagent

Manufacturer

Pointe Scientific, Inc.

Manufacturer Address
Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188
Manufacturer Parent Company (2017)
MedTest Holdings
Source
USFDA

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