Events

cobas p 612 pre-analytical system (LCP1). 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-2018-RN-00945-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-07-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00945-1
  • 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
    During internal investigations, roche diagnostics confirmed that in rare cases, sample material may come in contact with the pipetting nozzle during operation of the cobas p 612 pre-analytical system. this may lead to contamination of samples and, if a highly sensitive analytical technology is used e.G. molecular testing, inaccurate results may be produced.Cobas p 612 pre-analytical systems that use disposable filter tips are not affected by this issue.Roche has received no complaints worldwide for this issue; none from australian customers to date.
  • 조치
    Roche Diagnostics Australia is advising that the use of disposable filter tips in the cobas p 612 pre-analytical system will be mandatory until the root cause is identified and appropriate corrective actions have been implemented. Roche Diagnostics Australia will contact laboratories in due course to arrange the modifications required for using disposable filter tips. The root cause investigation is still ongoing. Roche will send an update as soon as the root cause is identified and corrective measures are available.

Device

cobas p 612 pre-analytical system (LCP1). An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    cobas p 612 pre-analytical system (LCP1). An in vitro diagnostic medical device (IVD).Affected part: ADP NozzleMaterial Number: 07563116001ARTG Number: 212706(Roche Diagnostics Australia Pty Limited - Instrument/analyser IVDs)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited