Events

Rapid Laboquick Anti-HIV 1/2 Rapid Test Cassette Rapid Test Kit 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Koroglu 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
    2013-12-12
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/test-rapide-d-orientation-diagnostique-laboquick-anti-hiv-1-2-cassette-rapid-test-kit-koroglu-retrait-de-produit
  • 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 12/12/2013, the Ansm distributed safety information to users of the Laboquick Anti-HIV Rapid Test Rapid Test Kit 1/2 Rapid Test Kit manufactured by the company Koroglu and distributed in France by the company AllDiag .. The users concerned, in France, have received the attached mail (12/12/2013) (31 KB). The competent European authorities have been informed of this measure by the ANSM. This information is addressed to the directors of health establishments, local correspondents of reactovigilance as well as to the medical biologists for diffusion to the users concerned .. Read also. Rapid Laboquick Anti-HIV ½ HIV test manufactured by Koroglu: Withdrawal, suspension of placing on the market and use (12/12/2013) - Information Point

Device

Rapid Laboquick Anti-HIV 1/2 Rapid Test Cassette Rapid Test Kit
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    Koroglu

Manufacturer

Koroglu
  • 제조사 모회사 (2017)
    Koroglu
  • Source
    LAANSM