International Medical Devices Database

Manufacturer Address
Arkray Factory USA, Inc., 5182 W 76th St, Minneapolis MN 55439-2900
Manufacturer Parent Company (2017)
Arkray Global Business Inc.
Source
USFDA
2 Events
- Recall of Device Recall SPOTCHEM II Basic Panel test strips
- Recall of Device Recall SPOTCHEM II Glucose test strips

2 devices in the database

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.

Device Recall SPOTCHEM II Glucose test strips

Model / Serial
Lot Number EA4M78
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 Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. || For the in vitro quantitative determination of glucose in human plasma from whole blood samples.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Arkray Factory USA, Inc.

2 devices in the database

Device Recall SPOTCHEM II Basic Panel test strips

Device Recall SPOTCHEM II Glucose test strips