Events

BD BACTEC ™ MGIT ™ 960 SIRE 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
    2004-11-23
  • 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-d-un-lot-du-dmdiv-trousse-bd-bactec-mgit-960-sire-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 November 23, 2004, Becton Dickinson withdrew from the market lot 4154541 (per 15.10.05) of the in vitro diagnostic medical device called BD BACTEC ™ MGIT ™ 960 SIRE Kit - reference 245123, following the identification of any mushroom / mold contamination of the BD BACTEC ™ MGIT ™ 960 SIRE supplement / lot 41400062 included in the above-mentioned package. Becton Dickinson directly informed the recipients of the offending lot by means of the enclosed message ( 23/11/2004) (14 KB). The competent authorities have been notified directly by the manufacturer. This information is addressed to the directors of health establishments and correspondents of reactovigilance for diffusion, if necessary, with the services concerned .. Message Becton Dickinson (23/11/2004 ) (14 KB)

Device

BD BACTEC ™ MGIT ™ 960 SIRE Kit
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON