Events

Novocastra Liquid Mouse Monoclonal Antibody Calretinin. 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-2016-RN-00563-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00563-1
  • 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
    In the event that the product is used with diluents other than those listed, it may not provide adequate staining. when used according to the instructions for use with appropriate positive controls, the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. in these instances, the absence of adequate staining of tissue is likely to result in a delay in obtaining the results of ihc / ish staining and, in a worst-case scenario, could cause a delay in the diagnosis or classification of a neoplasm.
  • 조치
    Leica is advising users to only use Novocastra Liquid Mouse Monoclonal Antibody Calretinin with the specified diluents. There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in situ staining. This action has been closed-out on 25/01/2017.

Device

Novocastra Liquid Mouse Monoclonal Antibody Calretinin. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Novocastra Liquid Mouse Monoclonal Antibody Calretinin. An in vitro diagnostic medical device (IVD)Product Code: 1ml NCL-L-CALRET-566Lot Numbers: 6025204, 6029060, 6036060Only to be used in combination with:Diluent Lot NumbersAR9352 SLBL4196V, SLBL8154V, SLBM1997V, SLBM3199VAR9352-CN SLBL8154V SLBM1997VRE7133-CE 6035000RE7133-CN 6035115ARTG Number: 178442
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd