Device product
Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070
Z-0619-2016
Product summary
- Event
- Event 72570
- Status
- Terminated
- Classification
- Class II
- Quantity
- 146
- Official record key
device-enforcement:Z-0619-2016
Official wording
Reason: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Code information: Lot Numbers: 845173002
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