Events

Genscreen HIV Ag/Ab Ultra. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bio-Rad Laboratories 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-2012-RN-00954-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-09-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00954-1
  • 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
    As a tga condition for product registration, the genscreen hiv ag/ab ultra was accepted for 9 months shelf life not 12 months as stated on the packaging. the genscreen hiv ag/ab ultra kit was distributed to customers after may 2011 without the warning label: "customers are advised to subtract 3 months from the expiry date to obtain the new expiry date of the kit".
  • 조치
    Customers are being advised that for lots within the TGA accepted shelf life investigation of result validity should be carried out as per the package insert and for lots used outside of the accepted shelf life retesting of patient samples should be considered at the discretion of the laboratories Clinical Laboratory Director.

Device

Genscreen HIV Ag/Ab Ultra. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Genscreen HIV Ag/Ab Ultra. An in vitro diagnostic medical device (IVD)Catalogue Numbers: 72386 and 72388Multiple lot numbersARTG Number: 134410
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd