Events

VIDAS TOXO IgM Assay (used for the detection of toxoplasmosis antibodies). An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Biomerieux 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-2016-RN-00159-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00159-1
  • 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
    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 while using with 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. in remote cases this may result in a delayed diagnosis and treatment for immunocompromised patients, organ transplanted patients, foetuses (in the case of gestational infection) and neonates.
  • 조치
    Biomerieux is advising users to not use heat inactivate sera before testing. Any concerns regarding previously generated results should be discussed with the Laboratory Director.

Device

VIDAS TOXO IgM Assay (used for the detection of toxoplasmosis antibodies). An in vitro diagnostic...
  • 모델명 / 제조번호(시리얼번호)
    VIDAS TOXO IgM Assay (used for the detection of toxoplasmosis antibodies). An in vitro diagnostic medical device (IVD)Reference Number: 30202Multiple Lot Numbers affectedARTG Number: 209618
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd