Devices

Device Recall Acute Care BHCG TestPak

Model / Serial
Lot Numbers: 445146002, 445201002, 445243002
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 BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method || Catalog Number: CBHCG || SMN:10445060
Manufacturer
Siemens Healthcare Diagnostics Inc
1 Event
- Recall of Device Recall Acute Care BHCG 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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