Events

Cobas EGFR MutationTest Kit(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-00091-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-02-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00091-1
  • 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
    The cobas egfr mutationtest, lot t08661 is generating false positive results for exon 20 insertion mutations (i.E., false mutation detected results). this mutation is typically only observed in 1-4% of the population depending on the geographic region. the issue is currently under investigation by roche. no other lots or pack sizes of this product are affected by this recall.
  • 조치
    Roche Diagnostics Australia is requesting the customers to review their stocks, discontinue use and discard all remaining units of the above lot number. Roche Diagnostics Australia is providing replacement kits to the customers. This action has been closed-out on 15/08/2016.

Device

Cobas EGFR MutationTest Kit(An in vitro diagnostic medical device (IVD))
  • 모델명 / 제조번호(시리얼번호)
    Cobas EGFR MutationTest Kit(An in vitro diagnostic medical device (IVD))Catalogue Number: 06471463190Lot Number: T08661ARTG number: 194319
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited