Events

LIFECODES HLA-C eRES SSO Typing Kit. 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-2016-RN-00591-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00591-1
  • 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
    It has been determined that the threshold set for hla-c eres probes 380, 382, 384 and 385 in lot number 10235b are set high and may result in false negative probe results. the probes resolve the following cwd alleles:• probe 380 resolves c*03:06• probe 382 resolves c*12:13• probe 384 resolves c*01:08 • probe 385 resolves c*08:06.
  • 조치
    Diagnostic Solutions is advising users a correction will be made by replacing the old HLA-C eRES MATCHIT! EXP file with a revised MATCHIT! EXP file, which is specific to this single lot. This action has been closed-out on 02/02/2017.

Device

LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)Product Code: TL628921Lot Number: 10235BProbes affected: 380, 382, 384, 385ARTG Number: 217872
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd