Events

EnVision Flex/HRP visualisation reagent, part of EnVision Flex/Flex+ Kits(For invitro diagnostics use. Intended for use in immunohistochemistry) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Dako 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-00964-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-10-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00964-1
  • 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
    Dako has determined that there is a defect in one lot of a buffer used in the manufacturing of some corresponding lots of the envision flex/hrp visualisation reagent. specifically, some instances of moderate-to-strong non-specific staining and overly-strong specific staining have been observed when this visualisation reagent was used with four antibodies against the biomarkers epstein-barr virus (ebv), mum-1, wilms’ tumor1(wt1) protein and smooth muscle actin (sma). negative control antibodies in the same run were negative, and did not show the non-specific staining.
  • 조치
    Dako is advising users to destroy any remaining lots of affected units. Dako is recommending that users re-evaluate test results from affected lots. This action has been closed-out on 25/08/2016.

Device

EnVision Flex/HRP visualisation reagent, part of EnVision Flex/Flex+ Kits(For invitro diagnostics...
  • 모델명 / 제조번호(시리얼번호)
    EnVision Flex/HRP visualisation reagent, part of EnVision Flex/Flex+ Kits(For invitro diagnostics use. Intended for use in immunohistochemistry)Multiple products affectedProduct Codes: K8000, K8002, K8023, K8010, K8012, K8024 and GV800Multiple Lot Numbers affectedARTG Number: 199416
  • Manufacturer
    Dako Australia Pty Ltd

Manufacturer

Dako Australia Pty Ltd