Cell Marque Rabbit Monoclonal Antibody. 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-2016-RN-01012-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-02
  • 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
    Cell marque has become aware certain lots of the rabbit monoclonal antibody exhibit an unacceptable immunohistochemistry (ihc ) test result. an investigation was undertaken which showed that lots 1335409a to 1335409f may exhibit a false negative result. false negative results are readily detected when appropriate tissue controls are used during testing. the manufacturer recommends the use of proper controls when performing ihc staining to detect this issue.
  • 조치
    Abacus ALS is advising users to destroy any remaining kits of the affected lots. Affected product will be replaced with unaffected kits or credit issued. This action has been closed-out on 02/03/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Cell Marque Rabbit Monoclonal Antibody. An in vitro diagnostic medical device (IVD)Product Code: S100A1 (EP184)Affected products: Cell Marque S100A1 rabbit EP184 0.1 concentrate Catalogue Number: 408R-14Cell Marque S100A1 rabbit EP184 1 concentrateCatalogue Number: 408R-16Lot numbers: 1335409A to1335409FARTG Number: 239099
  • Manufacturer

Manufacturer