Device Recall ABL90 FLEX Blood Analyzer

  • Modelo / Serial
    S/N 393-090R0059N007, 393-090R0061N008 & 393-090R0061N009
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of MI, NJ, & PA and countries Australia, Austria, Belgium, Denmark, Finland, France, Germany, Indonesia, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Arab Emirates & United Kingdom.
  • Descripción del producto
    ABL90 FLEX Blood Analyzer Part Number: 393-090. || Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA