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…

Recall date

November 11, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0613-2016

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics Inc

Sold / distributed

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,…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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