Events

Product-CD30 (Ber-H2) Incorrect Primary Antibody Expiration Dating 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-00690-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-07-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00690-1
  • 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
    Ventana medical systems, inc. (ventana) would like to inform you that the expiration date of the ventana cd30 (ber-h2) mouse monoclonal primary antibody (part number 790-4858, roche material number 07007841001) was inadvertently labelled with a 24 month expiration date for the referenced lot numbers. based on extensive testing of the affected lots, ventana can only support an 18 month expiration date.
  • 조치
    Roche is requesting their customers to stop use of the affected product. Roche is also recommending that any clinical cases tested after the actual expiration date be re-tested in accordance with your local laboratory practices and policies, especially if tissue and/or same-slide controls were not performed in association with the original case. This action has been closed-out on 05/09/2016.

Device

Product-CD30 (Ber-H2) Incorrect Primary Antibody Expiration Dating
  • 모델명 / 제조번호(시리얼번호)
    Product-CD30 (Ber-H2) Incorrect Primary Antibody Expiration DatingAffected lot numbers: D04835Z, D09123, E00209, E03668, E04391, E05896ARTG Number: 175635
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited