Events

cobas 8100 BRF and URF with software versions 02-xx. 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-2017-RN-00373-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00373-1
  • 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
    An issue regarding the reformatter modules urf and brf of the cobas 8100 automated workflow series (when used with software version 02-xx) has been identified. this issue is caused by an incorrect mechanical control sequence based on a limitation in software versions 02-xx, resulting in the racks to be shaken and specimen spillage. sample spillage may cause cross contamination of samples and potentially expose operators to infectious material.
  • 조치
    Until the installation of the software upgrade, Roche Diagnostics is advising users to ensure that the rack buffering function is disabled in the configuration of the Control Unit. In the event of a major spillage, users are advised to set the affected modules offline. These modules should be checked and cleaned by a Roche Service Representative before being returned to routine operation. This action has been closed-out on 15/03/2018.

Device

cobas 8100 BRF and URF with software versions 02-xx. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    cobas 8100 BRF and URF with software versions 02-xx. An in vitro diagnostic medical device (IVD)cobas 8100 automated workflow seriesBRF for cobas 8100Material Number: 07439954001URF for cobas 8100Material Number: 07441657001ARTG Number: 173887
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited