Events

Bulk Loader Module for cobas p 471 centrifuge unit(Automated clinical analytical systems designed to analyse biological samples for in vitro diagnostic purposes) 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-2015-RN-00923-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-09-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00923-1
  • 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 received a complaint that one sample tube was opened inadvertently in a bulk loader module (blm) during the internal system transport. the opened sample tube fell down into the funnel and the sample material was spilled, contaminating the system and other samples on their outer surface. sample material could not be used to carry out the analysis.
  • 조치
    To prevent the above malfunction, a hardware modification kit has been developed and will be released by the end of September 2015, with subsequent installation by a Roche field service engineer. Until the modification kit is installed Roche is requesting that if the issue occurs end users must carryout a complete instrument clean according to the Bulk Loader Module (BLM) operator manual. This action has been closed-out on 29/08/2016.

Device

Bulk Loader Module for cobas p 471 centrifuge unit(Automated clinical analytical systems designed...
  • 모델명 / 제조번호(시리얼번호)
    Bulk Loader Module for cobas p 471 centrifuge unit(Automated clinical analytical systems designed to analyse biological samples for in vitro diagnostic purposes)Part Number: 07084285001All Lot NumbersAll Software versionsARTG Number: 212706
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited