Events

Lactate membrane for ABL700 series and ABL800 series blood gas analysers (Part 942-066, D7077) . An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Radiometer Pacific Pty Ltd 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-01108-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01108-1
  • 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
    Potential enzyme residue on the outside of a newly replaced lactate membrane may cause an initial negative bias on the reported lactate result. if this residue exists the bias will decrease over the in-use time.
  • 조치
    Radiometer is providing work around instructions to mitigate the issue and are currently reviewing the manufacturing process to implement changes that will prevent the possibility of this occurrence

Device

Lactate membrane for ABL700 series and ABL800 series blood gas analysers (Part 942-066, D7077) . ...
  • 모델명 / 제조번호(시리얼번호)
    Lactate membrane for ABL700 series and ABL800 series blood gas analysers (Part 942-066, D7077) . An in vitro diagnostic medical device (IVD)All lot numbers affected
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd