Events

Xpert HIV-l Viral LoadAn in vitro medical device 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Cepheid Holdings 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-2018-RN-00012-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-01-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00012-1
  • 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
    Since beginning of 2017, three incidents of discrepant results were reported to the european competent authorities involving the xpert hiv-l viral load test and other alternative methods where the xpert hiv-1 viral load assay did not detect the variant of hiv.
  • 조치
    Cepheid recommends that each user of the Xpert HIV-l Viral Load test is informed about the update of the package insert which is now including the following additional limitation: “Rare mutations within the target region of the HIV-1 VL assay may affect primer and/or probe binding resulting in under-quantitation of virus.”

Device

Xpert HIV-l Viral LoadAn in vitro medical device
  • 모델명 / 제조번호(시리얼번호)
    Xpert HIV-l Viral LoadAn in vitro medical deviceCatalogue number - GXHIV-VL-CE-10ARTG Number 259967 (Cepheid Holdings Pty Ltd - Human immunodeficiency virus (HIV) IVDs)
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd