Events

Cell Marque CDX-2 (EPR2864Y*) antibody 7ml - an in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abacus ALS 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-2013-RN-00776-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-07-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00776-1
  • 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
    Cell marque cdx-2 is used to aid in the differentiation of colorectal adenocarcinoma and lung adenocarcinomas. the cdx-2 antibody typically stains the nuclei of colorectal carcinoma cells but not lung adenocarcinoma cells. abacus has advised that the cdx-2 antibody may exhibit a light sporadic, focal, nuclear staining in a limited number of lung adenocarcinomas such as those with enteric differentiation, and may demonstrate slightly stronger staining than other lots.
  • 조치
    Abacus ALS is requesting users to destroy affected stock. Replacement units will be provided as soon as possible. The requirement for a review of patient results reported from this lot should be determined by the laboratory director.

Device

Cell Marque CDX-2 (EPR2864Y*) antibody 7ml - an in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Cell Marque CDX-2 (EPR2864Y*) antibody 7ml - an in vitro diagnostic medical device (IVD)Catalogue Numbers: CM235R-17 and CM235R-18Lot Number: 1221903
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd