Events

SERODIA HIV;SERODIA HIV1/2 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BAYER DIAGNOSTICS 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
    1999-11-10
  • 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-reactifs-de-depistage-des-anticorps-anti-vih2
  • 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
    As part of its vigilance competence for the products for which it ensures safety, the Agency has reassessed the sensitivity of all HIV-1 antibody test reagents in accordance with protocol approved by the Advisory Committee for the Registration of Reagents. In view of the results of this re-evaluation and following the opinion of the Advisory Committee on the Registration of Reagents (CCER), the French Agency for the Safety of Health Products decided to withdraw from the market of six reagents on 16 June 1999 (message from June 17, 1999). In addition to these decisions, the Agency decided on 9 November 1999 to proceed with the removal of the SERODIA HIV and SERODIA HIV1 / 2 reagents from BAYER DIAGNOSTICS, given the impossibility of improving the performance of these reagents, including sensitivity was close to the acceptance criteria adopted by the CCER.

Device

SERODIA HIV;SERODIA HIV1/2
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BAYER DIAGNOSTICS

Manufacturer

BAYER DIAGNOSTICS
  • 제조사 모회사 (2017)
    Bayer AG
  • Source
    LAANSM