ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Diagnostic Solutions 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-01194-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-07
  • 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
    Diagnostic solutions has been informed by immuno concepts that incorrect calibrator has been included with affected lots of the ena relisa single well screen kits. this may result in over-sensitivity and false positive patient results.
  • 조치
    Diagnostic Solutions is advising users to inspect stock and destroy any remaining kits of the affected lots. Diagnostic Solutions is recommending that a review of previously reported results is performed at the discretion of the Laboratory Director. This action has been closed-out on 25/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD) Product Code: IC7696-10Lot Numbers:1525909 and 1525812 ARTG Number: 197980
  • Manufacturer

Manufacturer