Events

QConnect HBVNAT Positive 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Thermo Fisher Scientific Australia Pty Ltd 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-01050-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-11-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01050-1
  • 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
    Certain lot numbers of the qconnect hbvnat positive control may give no results due to ic (internal control) failure when run on the abbott m2000.The affected lot numbers should not be run on the abbott m2000.To ensure all affected lots have been destroyed the respective product specialist for each area will visit each site to confirm there is no stock still in possession.
  • 조치
    Users are asked to quarantine all affected units from use prior to destruction. To ensure all affected lots have been destroyed the respective Product Specialist for each area will visit each site to confirm there is no stock still in possession. This action has been closed-out on 22/08/2016.

Device

QConnect HBVNAT Positive

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd