Events

BD CD8 Phycoerythrin (PE) 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 manufacturer #1479 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
    17921
  • 사례 시작날짜
    2014-12-24
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • 원인
    It has been identified that the cd8 pe reagent has been contaminated with a low amount of cd4 fitc. it has been confirmed that the concentration of the cd8 antibody in the oe conjugate is sufficient to detect cd8 antigen on the targeted cells however the presence of cd4 could result in the possibility of an unexpected staining pattern., the concern with the above issue is that the cd4 cells will be expressed along the fitc axis. any marker that is stained on the fitc axis will contain this incorrectly stained cd4 population. subsequent downgating will make the data appear as if the cd4 population is not present.
  • 조치
    Product to be exchanged

Device

BD CD8 Phycoerythrin (PE)
  • 모델명 / 제조번호(시리얼번호)
    Model: 340046, Affected: 4220622
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479