Devices

Device Recall AB SCIEX

  • 모델명 / 제조번호(시리얼번호)
    Software Version: MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) Internationally to Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,
  • 제품 설명
    AB SCIEX QTRAP¿ 4500MD LC/MS/MS System || Mass Spectrometer for In-Vitro Diagnostic Use. || Instrument Part Number (REF): 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
    Ab Sciex
  • 4 Events

제조사

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

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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
    Clinical Chemistry and Clinical Toxicology Devices
  • 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
    Ab Sciex
Device Recall AB SciexTriple Quad 4500MD LC/MS/MS System.
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers:  Triple Quad 4500MD LC/MS/MS System BX21081601 BX21101601 BX21091601 BX21111601 BX21121602 BX21131602 BX21141602 BX21151602  QTRAP 4500MD LC/MS/MS System BW20251601 BW20241601 BW20261602
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed to the state of NC.
  • 제품 설명
    AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. || Mass spectrometers for in vitro diagnostic use only.
  • Manufacturer
    Ab Sciex
Device Recall AB SCIEX
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: BV20031308, BV20081311, BV20051310, BV20071311, BV20101401, BV20131401
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    FL, NC, OK, PA, TX
  • 제품 설명
    AB SCIEX API 3200MD" LC/MS/MS System with software: || MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens || Part Number 5024543.
  • Manufacturer
    Ab Sciex