Events

Xpert HIV-1 Viral Load Assay. An in vitro diagnostic medical device (IVD). 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-2016-RN-01272-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-10-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01272-1
  • 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
    Cepheid has received reports that some customers have experienced cartridge performance issues that manifest as abnormal pcr amplification curve patterns, which can yield invalid results (the most common outcome), or much less commonly, inaccurate quantification of hiv-1 rna when using this test and its intended use specimen types.
  • 조치
    Cepheid is advising users to stop using and dispose of any remaining product from the affected lot (Lot Number 1000034821). Replacement product will be provided. The results of previous tests performed with this lot of product should be discussed with the laboratory medical director to determine whether a look-back is required. If there are any concerns about the accuracy of the results contact Cepheid Technical Support who will analyse the GeneXpert data files (gxx files). This action has been closed-out on 10/05/2017.

Device

Xpert HIV-1 Viral Load Assay. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    Xpert HIV-1 Viral Load Assay. An in vitro diagnostic medical device (IVD).Catalogue Number: GXHIV-VL-CE-10 Lot Number: 1000034821 (Cartridge Lot: 14001)Expiration Date : 09 October 2016ARTG Number: 259967
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd