Events

Alegria Anti-Intrinsic Factor Assay 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Immuno 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-2014-RN-00546-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00546-1
  • 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
    Analysis in quality control has identified and confirmed that the lots listed above of our alegria test org 247, anti-intrinsic factor, exhibit an overall lower level of optical density values. this effect bears the risk that some positive sample-values will fall below the cut-off and will falsely be read as negative.
  • 조치
    Immuno requested thier customers to destroy any remaining product from the affecetd lots. Due to the risk of false negative results Immuno recommended that negative samples where clinical symptoms of pernicious anaenia should be retested. This action has been closed-out on 18/02/2016.

Device

Alegria Anti-Intrinsic Factor Assay
  • 모델명 / 제조번호(시리얼번호)
    Alegria Anti-Intrinsic Factor AssayProduct Code: ORG 247-24Lot Numbers: 24732425, 24732427 & 24733840
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA