Various mass spectrometers - Quattro micro, ACQUITY TQD, Quattro Premier XE, Xevo TQ; In vitro diagnostic medical devices (IVD's) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2012-RN-01068-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-10-22
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    There is a possibility that the ion block source heater may fail. in some instances, the failure could cause short term loss or variation of sensitivity that may subsequently lead to inaccurate data. the loss of or variation in sensitivity is most pronounced in assays with shorter dwell times and may not always be detected by quality control and internal standard value monitoring.
  • 조치
    Customers to contact their Waters field service engineer to order a replacement part (ion block source heater).

Device

  • 모델명 / 제조번호(시리얼번호)
    Various mass spectrometers - Quattro micro, ACQUITY TQD, Quattro Premier XE, Xevo TQ; In vitro diagnostic medical devices (IVD's)Quattro microPart:VB-QMicroSerial Numbers:QAA1167, QAA412, QAA742, QAA65, QAA765, QAA802 & QAA836ACQUITY TQDPart:186003875Serial Numbers:QBA470, QBB795, QBB924 & QBB928Quattro Premier XEPart:186003250Serial Numbers:VAB1000, VAB1215, VAB610, VAB844, VAB845 & WAB998Xevo TQPart:186004490Serial Numbers: VBA626 & VBA744ARTG Number: 201727
  • Manufacturer

Manufacturer