Events

Cobas 4800 HPV Amplification/Detection Reagents, 240 tests and 960 tests240 tests 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-2013-RN-00752-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2013-07-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00752-1
  • 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 an internal investigation, a formulation error was identified during the manufacture of the cobas 4800 hpv master mix reagent leading to an increased rate of invalid runs. this issue does not cause incorrect specimen results, however results from failed runs must be repeated.
  • 조치
    Roche is requesting users to discontinue use and discard all units from the affected lots. Roche will replace any affected units.

Device

Cobas 4800 HPV Amplification/Detection Reagents, 240 tests and 960 tests240 tests
  • 모델명 / 제조번호(시리얼번호)
    Cobas 4800 HPV Amplification/Detection Reagents, 240 tests and 960 tests240 testsPart Numbers: 05235901190Lot Numbers: R15771 960 testsPart Numbers: 05235910190Lot Numbers: R15304
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited