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
    2004-08-11
  • 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-de-dmdiv-bactec-mgit-960-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
    Becton Dickinson withdraws from the market. lot 4028645 (version 03.06.05) of the in vitro diagnostic medical device called BD BACTEC ™ MGIT ™ 960 SIRE Kit - reference 245123. batch 4076878 (version 23.06.05) of the in vitro diagnostic medical device known as the BD BACTEC ™ MGIT ™ 960 INH Kit 0.4 - reference 245126. batch 4076881 (version 23.06.05) of the in vitro diagnostic medical device called BD BACTEC ™ MGIT ™ 960 EMB 7.5 kit - reference 245127. following evidence of fungal / mold contamination of the BD BACTEC ™ MGIT ™ 960 SIRE / lot 3351099 supplement included in the above listed kits; this contamination can lead either to invalid results (positive growth control before 4 days), or, potentially, to a false interpretation of resistance to the anti-TB drugs tested. These devices are used for the rapid detection of the sensitivity of Mycobacterium tuberculosis to antimycobacterial agents. (streptomycin, isoniazid, rifampicin, ethambutol).

Device

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

Manufacturer

BECTON DICKINSON