Events

Retiro De Equipo (Recall) de 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

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por INGE;MUREX DIAGNOSTICS;DIASORI;ROCHE DIAGNOSTIC;PBS ORGENICS;ORTHO CLINICAL DIAGNOSTIC;SANOF; DIAGNOSTICS PASTEUR.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    1999-06-17
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-reactifs-de-depistage-des-anticorps-anti-vih3
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Acción
    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