Events

ACQUITY UPLC Sample Organisers. An in vitro diagnostic medical device (IVD) 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-2017-RN-00481-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-04-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00481-1
  • 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
    The manufacturer, waters corporation has identified an issue with the acquity uplc sample organisers, whereby there is a potential for an internal fuse shield to combust, resulting in a burning odour and instrument failure. an investigation concluded that the potential combustion of the fuse shield would be contained within the instrument with no risk of damage to the samples or the surrounding areas.
  • 조치
    Emergo will send a field engineer to attend the user's facility to modify the affected device (by removing the internal fuse). In the interim, users are advised that if they note a burning odour in or around the instrument, to immediately power down the unit, discontinue use, and call their local representative to report the event.

Device

ACQUITY UPLC Sample Organisers. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    ACQUITY UPLC Sample Organisers. An in vitro diagnostic medical device (IVD)Model Number: 186015020IVDLot Numbers: G13UPO544M, J13UPO553M, G13UPO542MARTG Number: 201428
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia