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Siemens Healthcare Diagnostics Inc recalls Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute
Recalled January 13, 2016 · FDA recall Z-0617-2016 · Siemens Healthcare Diagnostics
Hazard
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems · FDA Class II
Units
196
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 BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061
Manufacturer(s)
Siemens Healthcare Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →