Device Recall reference electrode membranes / A8L8X7 Flex Creatinine Analyzer

  • Modèle / numéro de série
    Part Number: 942-058, Article Number: D711
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The recalled product was distributed customers located in the following states within the U.S.: CT, FL, GA, IL, MA, MD, MN, MO, NC, NM, OH, PA, VA, WA, WI, and WV. Product was also sold in the following countries: Algeria, Australia, Austria, Bahrain, Brazil, Czech Rep., Denmark, England, Estonia, France, Germany, Greece, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland & Turkey.
  • Description du dispositif
    Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box.
  • Manufacturer
  • 1 Event

Fabricant

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