Device product
Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic
Z-0611-2016
Product summary
- Event
- Event 72570
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2647
- Official record key
device-enforcement:Z-0611-2016
Official wording
Reason: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Code information: Lot Numbers: 405131002, 405173002, 405187002, 405208002, 405229002 405278002, 405292002
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