Device product
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
Z-0615-2016
Product summary
- Event
- Event 72570
- Status
- Terminated
- Classification
- Class II
- Quantity
- 590
- Official record key
device-enforcement:Z-0615-2016
Official wording
Reason: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Code information: Lot Numbers: 445146002, 445201002, 445243002
Distribution pattern: 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.
Derived failure modes
-
Unknown
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems