Devices

Device Recall Acute Care CTNI TestPak

Model / Serial
Lot Numbers: 235151002, 235159002, 235166002, 235173002, 235208002 235215002, 235222002, 235229002, 235236002, 235243002 235250002, 235257002, 235278002, 235285002
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
Product Description
Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma || Catalog Number: CCTNI || SMN: 10445071
Manufacturer
Siemens Healthcare Diagnostics Inc
1 Event
- Recall of Device Recall Acute Care CTNI TestPak

Manufacturer

Siemens Healthcare Diagnostics Inc

Manufacturer Address
Siemens Healthcare Diagnostics Inc, 2 Edgewater Dr, Norwood MA 02062-4637
Manufacturer Parent Company (2017)
Siemens Ag
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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