Device Recall reference electrode membranes / A8L8X7 Flex Creatinine Analyzer

  • Model / Serial
    Part Number: 942-058, Article Number: D711
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
  • Manufacturer Parent Company (2017)
  • Source
    USFDA