Device Recall Stratus CS Acute Care Diagnostics System

  • Model / Serial
    All software versions and serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, U.A.E., Algeria, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Canada, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Namibia, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
  • Product Description
    Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument || that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. || SMN: 10444834, 10453531
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Dr, Norwood MA 02062-4637
  • Manufacturer Parent Company (2017)
  • Source
    USFDA