Device product
Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068
Z-0613-2016
Product summary
- Event
- Event 72570
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1051
- Official record key
device-enforcement:Z-0613-2016
Official wording
Reason: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Code information: Lot Numbers: 245138002, 245152002, 245215002, 245262002
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