Dengue NS1 Ag Strip 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-2015-RN-01238-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-22
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    There has been a sudden degradation of the sensitivity of certain lots of dengue ns1 ag strips, which has resulted in false negative results for positive patient samples.
  • 조치
    Bio-Rad is advising users to inspect stock (including units currently in use) and discard the affected units. Affected lots will be replaced. This action has been closed-out on 30/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Dengue NS1 Ag StripCatalogue Number: 70700Serial/Lot Numbers:5F0130 Expiry Date: 30 March 20165H0131 Expiry Dates: 30 April 2016 and 15 May 20165H1131 Expiry Dates: 30 April 2016 and 15 May 20165H2131 Expiry Dates: 30 April 2016 and 15 May 2016ARTG Number: 207118An in vitro diagnostic medical device (IVD)
  • Manufacturer

Manufacturer