Siemens Healthcare Diagnostics Inc recalls Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (A

Recalled January 13, 2016 · FDA recall Z-0613-2016 · Siemens Healthcare Diagnostics

Hazard

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems · FDA Class II

Units

1051

Sold at

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.

Description

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

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

Manufacturer(s)

Siemens Healthcare Diagnostics Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →