Events

Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Leica Microsystems 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-00892-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-09-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00892-1
  • 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
    Leica biosystems recently became aware that the novocastra lyophilised mouse monoclonal antibody cd10 reagent lots do not function as intended up to the expiry date on the product labelling. there is a link between the age of the product and staining intensity, which may result in inadequate staining and lead to weak or false negative pathology results. this could potentially result in misclassification of a neoplasm and inappropriate management.
  • 조치
    Leica Biosystems is advising users to cease use and destroy any remaining stocks of affected product. A review of previously obtained results is recommended at the discretion of the laboratory director and physician. This action has been closed-out on 03/03/2017.

Device

Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents. An in vitro diagnostic medical de...
  • 모델명 / 제조번호(시리얼번호)
    Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents. An in vitro diagnostic medical device (IVD).Product Code: CD10-270-CELot Number: 6032742ARTG Number: 178442
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd