Device Recall reference electrode membranes / A8L8X7 Flex Creatinine Analyzer

  • Modelo / Serial
    Part Number: 942-058, Article Number: D711
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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

Fabricante

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