Events

Difco ™ BBL ™ Gram Crystal Violet Kit 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BECTON DICKINSON 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
    2004-10-13
  • 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-dmdiv-difco-bbl-gram-crystal-violet-de-par-becton-dickinson
  • 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
    On October 12, 2004, Becton Dickinson withdrew batches 4226886 and 4226882 (P / N 28.05.05) from the in vitro diagnostic medical device called Difco ™ BBL ™ Gram Crystal Violet Kit - references 212525 and 212526 respectively, continued the detection of a possible lack of development of the appropriate coloration characteristic of gram-positive organisms. The company Becton Dickinson directly informed the recipients of the incriminated lots by means of the attached message (12/10/2004) ( 19 ko The competent authorities have been notified directly by the industrialist.This information is addressed to the directors and correspondents of réactovigilance for diffusion, if necessary, to the services concerned.

Device

Difco ™ BBL ™ Gram Crystal Violet Kit
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON