Events

cobas MPX test. 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-00356-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00356-1
  • 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
    Globally, roche has received a number of customer reports of selected lots of the cobas mpx test generating unexpected initial false reactive results, which do not match the serology profile of the sample. roche diagnostics australia has received no reports of false reactive results with the affected lot numbers from australian customers.
  • 조치
    Roche is requesting users to discontinue use of and discard any remaining inventory of the affected lots, on receipt of replacement unaffected stock. A Roche Diagnostics Australia representative will be in touch with any affected customers to arrange replacement stock.

Device

cobas MPX test. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    cobas MPX test. An in vitro diagnostic medical device (IVD). Material Number: 06997708190 (96 tests)Lot Numbers: 242567 and 267989ARTG Number: 275469Roche Diagnostics Australia - cobas MPX. - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited