Events

bioMerieux VIDAS TOXO IgM 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Biomerieux SA 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
    19787
  • 사례 시작날짜
    2016-02-26
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • 원인
    Following a complaint from a customer related to discrepant results observed when testing heat inactivated sera, biomérieux performed an investigation concluding that the performance of vidas toxo igm kit using heat inactivated sera (56°c for 30 minutes) is not in accordance with the performance characteristics as stated in the ifu. the investigation confirmed that the index results obtained with inactivated sera are lower compared to values obtained with fresh sera and may result in false negative results.
  • 조치
    Product to be returned to supplier

Device

bioMerieux VIDAS TOXO IgM
  • 모델명 / 제조번호(시리얼번호)
    Model: 30202, Affected: multiple lot numbers
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA