Device Recall reference electrode membranes / A8L8X7 Flex Creatinine Analyzer

  • 모델명 / 제조번호(시리얼번호)
    Part Number: 942-058, Article Number: D711
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
  • 제조사 모회사 (2017)
  • Source
    USFDA