Events

COBAS INTEGRA 800 Software Version 9864.C2. 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-00926-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-09-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00926-1
  • 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
    A software bug has been detected in the cobas integra 800 software version 9864.C2 which affects the execution of routine maintenance of the ise module. the issue is caused by the ise counters in the software being reset to zero whenever the ise rack is removed from the analyser. lf ise service actions and manual maintenance items are not executed at their recommended intervals, there is a potential risk of increased occurrence of calibration flags (slope, sol i dev etc), as well as incorrect and unflagged ise results.
  • 조치
    Roche is currently working on a software fix expected to be implemented by the end of the year. Until the software is available, Roche recommends that operators manually track all ISE counters and to manually request the corresponding Service Action in the Service Software.

Device

COBAS INTEGRA 800 Software Version 9864.C2. An in vitro diagnostic medical device (IVD).

Manufacturer

Roche Diagnostics Australia Pty Limited