Events

MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Diagnostic Solutions 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-2017-RN-01303-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01303-1
  • 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
    Diagnostic solutions has been advised that as a result of a complaint investigation, it has been determined that mia fora ngs software is impacted by an error in the v3.27.0 reference database update. customers testing all 11 hla genes, 9 hla genes and 6 hla genes with the mia fora ngs flex hla kits are impacted. reference sequences specific to hla-drb6 and other non-target reference sequences were inadvertently omitted from the v3.27.0 reference database and as a result, this may impact the accuracy of the automatic calls and the need to manually review results. this is most frequently observed with hla-dpb1 results.
  • 조치
    Diagnostic Solutions will be in contact with users when a software update is available to include the revised reference database. In the interim, users may utilise either of the following options: 1. Continue use of the v3.27.0 reference database and manually inspect all DPB1 results pending availability of the corrected database; or 2. Revert to v3.24.0. Guidance on how to do this may be provided upon request by Immucor. Note: after reverting to v3.24.0 users must reanalyse projects previously analysed with the v3.27.0 reference database using the v3.24.0 reference database.

Device

MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)ARTG Number: 288607
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd