Device Recall Stratus CS Acute Care Diagnostics System

  • Modèle / numéro de série
    All software versions and serial numbers
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Dr, Norwood MA 02062-4637
  • Société-mère du fabricant (2017)
  • Source
    USFDA