Cobas c 501 / c 502 and COBAS INTEGRA. 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-2015-RN-00229-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-17
  • 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
    Following customer complaints regarding a 20% decrease in control levels when using third party controls (e.G. thermofisher liqimmune) roche has identified that reagent lot 697811 shows a negative bias of up to 54% compared to lot 604303.This negative bias could, in the worst case, lead to inaccurately low homocysteine results.This issue only occurs with edta plasma samples.
  • 조치
    Roche is requesting their customers to discard any remaining units from the affected lot. This action has been closed-out on 18/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Cobas c 501 / c 502 and COBAS INTEGRA. An in vitro diagnostic medical device (IVD)Material Number: 05 385 415 190Affected lots: 69781101Expiry Date: 30 Apr 2015Subsequent lots: 60717101Expiry Date: 31 Jan 2016
  • Manufacturer

Manufacturer