NCL-L-CD15. An in vitro diagnostic medical device (IVD).(NovocastraT Liquid Mouse Monoclonal Antibody) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Leica Biosystems Melbourne 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-2014-RN-01357-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-12-23
  • 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
    Leica biosystems recently became aware that the product listed above does 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. no customer complaints relating to this issue have been received. there is the potential risk of a patient being diagnosed with incorrect tumor based on a false negative cd15 staining result. delay in diagnosis/ misdiagnosis of a patient with hodgkin’s disease. positive control tissue would show weaker than expected or negative staining. an unexpected result would be highlighted by the use of appropriate controls. additionally, if a pathologist did not follow standard medical practice there could be a possibility that an incorrect or delayed diagnosis could result and appropriate treatment for the patient could be delayed. this could possibly result in improper staging of the patient’s disease or resulting in the patient’s death.
  • 조치
    End users are requested to discard any remaining product from the affected lot and contact their Leica representative immediately if a replacement is required.

Device

Manufacturer