Skip to content
Recall Observatory FDA recall evidence

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

November 11, 2015

Class II

Product summary

Firm
Siemens Healthcare Diagnostics Inc
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

    reason.no_named_rule · v1.0.0

    Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems