Device Recall Digital Fluidics PCB

  • 모델명 / 제조번호(시리얼번호)
    IMMULITE 2000: Serial Numbers M5080 to M5137; and IMMULITE 2500: Serial Numbers F0778 to F0818.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution to states including MA, NY, PA, MD, GA, FL, OH, IN, MI, IL, MO, LA, UT, AZ and CA and countries of Canada, Czech Republic, Germany, Poland, Hungary, Belgium, Russia, Republic of South Africa, Greece, Israel, Turkey, Spain, Portugal, Denmark, France, Great Britain, India, China, South Korea and Mexico.
  • 제품 설명
    Immulite 2000 and Immulite 2500 digital Fluidics PC Board, || Part Number 450116-0002. || Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Medical Solutions Diagnostics, 62 Flanders-Bartley Rd, Flanders NJ 07836-4715
  • 제조사 모회사 (2017)
  • Source
    USFDA