Devices

Device Recall SPOTCHEM II Basic Panel test strips

Model / Serial
Lot Number PN5C26
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
Product Description
arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. || For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.
Manufacturer
Arkray Factory USA, Inc.
1 Event
- Recall of Device Recall SPOTCHEM II Basic Panel test strips

Manufacturer

Arkray Factory USA, Inc.

Manufacturer Address
Arkray Factory USA, Inc., 5182 W 76th St, Minneapolis MN 55439-2900
Manufacturer Parent Company (2017)
Arkray Global Business Inc.
Source
USFDA

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