ONLINE DAT Cannabinoids II / 100 tests / 200 testsLot numbers: 698113, 604195, 604194, 696131, 698110 & 696133 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-00157-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-03-06
  • 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
    Internal investigations by roche diagnostics verified that the within run precision (cv) for the positive/negative control with different reagent lots is approximately 10%. the specification is lower than 8%. patient sample results which are very close to the cutoff might recover below the cutoff. the affected reagent lots expire in may 2015. newer lots are not affected by the precision issue and can be used as a replacement.
  • 조치
    Roche is requesting their customers to discard any remaining stock of THC II from reagent lots 69811301 and 60419501. This action has been closed-out on 02/03/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    ONLINE DAT Cannabinoids II / 100 tests / 200 testsLot numbers: 698113, 604195, 604194, 696131, 698110 & 696133 ARTG number: 174911
  • Manufacturer

Manufacturer