Device Recall AB Sciex API 3200MD, 3200MD QTRAP, Triple Quad, QTRAP 4500MD LC/MS/MS Systems

  • 모델명 / 제조번호(시리얼번호)
    Software Versions: Version 1.6.1 and 1.6.2
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) and Internationally to the following countries: AUSTRIA CANADA CHINA FRANCE GERMANY INDIA IRELAND ITALY KOREA MALAYSIA NETHERLANDS NORWAY RUSSIA SINGAPORE SPAIN SWITZERLAND UNITED KINGDOM
  • 제품 설명
    Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP¿ 4500MD LC/MS/MS System, Instrument Part Number: 5031231 || 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ab Sciex, 500 Old Connecticut Path, Framingham MA 01701-4574
  • 제조사 모회사 (2017)
  • Source
    USFDA