Device Recall Stratus CS Acute Care Diagnostics System

  • Modelo / Serial
    All software versions and serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Dr, Norwood MA 02062-4637
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA