Events

Elecsys HIV combi PT assay. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Roche Diagnostics Australia Pty Limited 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-2014-RN-00030-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-01-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00030-1
  • 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
    Recent cases have been reported of a calibration signal shift regarding the elecsys hiv combi pt assay (gmmi kit: 05390095-190) on modular analytics e170, cobas e 601 and e 602 analysers.The reagent packs reporting a calibration signal shift are affected during their use on the instrument. the affected on-board rack packs are identified by the hiv control level 1 (pc hiv level 1) recovering out of range (>3sd) during use.
  • 조치
    Roche Diagnostics is recommending that if users are affected to not re-calibrate the rack pack, discontinue use of the affected pack, record rack pack details of QC and Calibration signals and use a fresh rack-pack with new calibration and follow the instructions given in the package insert. Discarded kits will be replaced by Roche Diagnostics. Roche Diagnostics are continuing to investigate the cause of the issue and will advise users when further information is available. This action has been closed-out on 29/01/2016.

Device

Elecsys HIV combi PT assay. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Elecsys HIV combi PT assay. An in vitro diagnostic medical device (IVD)Lot numbers: 171983, 172659, 173326, 175019, 175493, 175494
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited