Device Recall ADVIA Centaur TnIUltra Assay

  • 모델명 / 제조번호(시리얼번호)
    All lots. 500 tests: Part/Catalog #02790309, and 100 tests: Part/Catalog # 02789602.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA, Argentina, Austria, Australia, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela
  • 제품 설명
    ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Medical Solutions Diagnostics, 511 Benedict Avenue, Tarrytown NY 10591-5005
  • 제조사 모회사 (2017)
  • Source
    USFDA