Events

Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. 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-2016-RN-01279-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-10-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01279-1
  • 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 is updating the cleaning procedure for rack trays that are used with various cobas, modular analytics and urisys instruments as a result of reports of injury caused by sharp edges on the rack trays during cleaning. cuts may occur when fingers come in contact with rack tray edges, especially if a quick wiping movement is made along the edges of the rack tray. the updated cleaning procedure contains instructions for safe handling of the parts to avoid the risk of injury.
  • 조치
    Roche is providing users with updated cleaning instructions for the rack trays. This information will be incorporated into future versions of the respective instrument Operator Manuals. This action has been closed-out on 17/05/2017.

Device

Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. An in vitro diagnos...
  • 모델명 / 제조번호(시리얼번호)
    Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. An in vitro diagnostic medical device (IVD). Various Rack Trays and instruments affectedMultiple Material Numbers affectedARTG Numbers: 173887 & 212706
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited