Events

cobas 4800 - z 480 (Real time PCR sample preparation, amplification and detection instrument). 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-2013-RN-00278-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-03-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00278-1
  • 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
    Roche has advised that in rare instanced channel shifted results have been generated with cobas 4800 assays run on v1.X software of the cobas 4800 system. raw data review indicates that in these cases, all signals are shifted by one channel:- channel 1 results report as channel 2- channel 2 results report as channel 3- channel 3 results report as channel 4- channel 4 results report as channel 1. in the reported cases the results of the runs were either invalid or the preponderance of individual patient specimen showed to be invalid.
  • 조치
    Roche is providing end users with work around instructions to mitigate the issue. A software update to detect and mitigate the issue will be implemented in late 2013. This action has been closed-out on 28/01/2016

Device

cobas 4800 - z 480 (Real time PCR sample preparation, amplification and detection instrument). An...
  • 모델명 / 제조번호(시리얼번호)
    cobas 4800 - z 480 (Real time PCR sample preparation, amplification and detection instrument). An in vitro diagnostic medical device (IVD).All serial numbers affected
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited