Cobas 8000 Patient sample and control recovery on Cobas c 701/702 modules (clinical chemistry analyser). 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-2012-RN-01113-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-01
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 on the cobas 8000, cobas c 701/702 modules, which under certain conditions can lead to a mismatch between reagent probe positioning during pipetting and the aspirate sample volumes, leading to possible incorrect results. until the new software version is available, roche have updated the application e-barcodes for the affected assays, which reduce the number of available tests.
  • 조치
    Roche will be providing work around instructions to mitigate the risk and will be providing a software update to permanently correct the issue.

Device

  • 모델명 / 제조번호(시리얼번호)
    Cobas 8000 Patient sample and control recovery on Cobas c 701/702 modules (clinical chemistry analyser). An in vitro diagnostic medical device (IVD)Multiple affected assays
  • Manufacturer

Manufacturer