Events

LIAISON Biotrin Parvovirus B19 IgM 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 DiaSorin Australia 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-00879-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-08-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00879-1
  • 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
    Diasorin has become aware that the kit lots identified have a potential to produce an increased rate of positive results when used on liaison xl analyzer.
  • 조치
    DiaSorin is recommending the retesting of all specimens resulting in an initial positive on the LIAISON XL analyzer unless, as part of the laboratory policy, these samples have already been confirmed by other method or by clinical evidence. The affected lots can still be used, but confirming all initially positive results with a different method or analyzer. DiaSorin is offering Parvovirus B19 IgM EIA, code V619IM free of charge to perform the retesting. This action has been closed-out on 03/06/2016.

Device

LIAISON Biotrin Parvovirus B19 IgM
  • 모델명 / 제조번호(시리얼번호)
    LIAISON Biotrin Parvovirus B19 IgMPart Number: 317010Lot Number: 129022X, 129022X/1Expiry Date: 12 December, 2014ARTG Number: 203754An in vitro diagnostic medical device (IVD)
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd