Devices

Device Recall STAIA PACK cTnI 2nd GenTroponin

Model / Serial
All Lot Codes
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
Product Description
ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 || Assay, Cardiac Marker
Manufacturer
Tosoh Bioscience Inc
1 Event
- Recall of Device Recall STAIA PACK cTnI 2nd GenTroponin

Manufacturer

Tosoh Bioscience Inc

Manufacturer Address
Tosoh Bioscience Inc, 3600 Gantz Rd, Grove City OH 43123-1895
Manufacturer Parent Company (2017)
Tosoh Corp.
Source
USFDA

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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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