Events

KALLESTAD / Blades Hep2 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Bio-Rad 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
  • 날짜
    2003-03-19
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-du-dispositif-medical-de-diagnostic-in-vitro-denomme-kallestad-lames-hep2-ref--30469-30470-30845-de-la-societe-bio-rad
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • 데이터 추가 비고
  • 조치
    The company Bio-Rad withdraws from the market lot 915005 (per 06.05.03) of reference 30470 and lot 916338 (per 06.05.03) of reference 30845 of the in vitro diagnostic medical device called KALLESTAD / Blades Hep2 - references 30469/30470/30845 (respectively 24, 12 and 6-well blades), following customer complaints resulting from results rendered falsely negative during a national quality control organized by the AFSSAPS. These blades manufactured according to a the "old generation" procedure appear to be less efficient than blades made according to a "new generation" procedure. This device allows the detection and semi-quantitative determination of anti-nuclear autoantibodies by indirect immunofluorescence technique.

Device

KALLESTAD / Blades Hep2
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad