Devices

Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI)

Model / Serial
Lot # 235276002; 235283002; 235290002; 235297002; 235304002; 235311002, 235318002; 235325002; 235338002; 235339002; 235346002; 235353002; 235361002; 236009002; 236016002; 236023002; 236030002; 236037002; 236044002; 236051002; 236058002; 236065002; 236072002; and 236079002.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
Product Description
Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI) in vitro diagnostic.
Manufacturer
Dade Behring , Inc.
1 Event
- Recall of Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI)

Manufacturer

Dade Behring , Inc.

Manufacturer Address
Dade Behring , Inc., 500 GBC Dr., Mailstop 514, PO BOX 6101, Newark DE 19714-6101
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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