Siemens Healthcare Diagnostics Inc recalls Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasm

Recalled January 13, 2016 · FDA recall Z-0609-2016 · Siemens Healthcare Diagnostics

Hazard

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

Units

5558

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 CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071

Manufacturer(s)

Siemens Healthcare Diagnostics Inc

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