Device Recall ABL90 FLEX Blood Analyzer

  • Modèle / numéro de série
    S/N 393-090R0059N007, 393-090R0061N008 & 393-090R0061N009
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
  • Société-mère du fabricant (2017)
  • Source
    USFDA