Events

Innotest HIV Ab 1.0.2.;Murex ICE HIV-1.0.2;Cobas Core anti-HIV-1/HIV-2 EIA DAGS;HIV 1+2 Double Check;Multispot HIV-1/HIV-2;Genie II HIV-1/HIV-2 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 INGE;MUREX DIAGNOSTICS;DIASORI;ROCHE DIAGNOSTIC;PBS ORGENICS;ORTHO CLINICAL DIAGNOSTIC;SANOF; DIAGNOSTICS PASTEUR 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
    1999-06-17
  • 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-vih3
  • 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 Consultative Commission for the Registration of Reagents. In view of the results of this re-evaluation and after consulting the Consultative Commission for the Registration of Reagents, the French Agency for the Safety of Health Products has decided to withdraw from the market the following reagents. Innotest HIV Ab 1.0.2. (ref: K1076 / K1077) of the INGE Company. Murex ICE HIV-1.0.2 (ref: 100A / 150A / 200A) from MUREX DIAGNOSTICS and DIASORI Companies. Cobas Core anti-HIV-1 / HIV-2 EIA DAGS (Ref: 756059) of ROCHE DIAGNOSTIC. HIV 1 + 2 Double Check (ref: 332000) from the companies PBS ORGENICS and ORTHO CLINICAL DIAGNOSTIC. Multispot HIV-1 / HIV-2 (ref: 72269) from SANOF. and Genie II HIV-1 / HIV-2 (ref: 72323) DIAGNOSTICS PASTEUR

Device

Innotest HIV Ab 1.0.2.;Murex ICE HIV-1.0.2;Cobas Core anti-HIV-1/HIV-2 EIA DAGS;HIV 1+2 Double Ch...

Manufacturer

INGE;MUREX DIAGNOSTICS;DIASORI;ROCHE DIAGNOSTIC;PBS ORGENICS;ORTHO CLINICAL DIAGNOSTIC;SANOF; DIA...
  • Source
    LAANSM