Events

Retiro De Equipo (Recall) de Genscreen Plus HIV Ag-Ab

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 Bio-Rad.

¿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
    2005-06-28
  • 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-lots-du-dmdiv-genscreen-plus-hiv-ag-ab-bio-rad
  • 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
    On June 24, 2005, Bio-Rad removed the lot from the market. 4M0051 (per 30/05/2006). 4L0576 (per 15/04/2006). 4L1576 (per 15/04/2006). 4L0577 (per 30/04/2006). 5A0578 (30/05/2006). 5B0579 (per 15/06/2006) of the in vitro diagnostic medical device known as Genscreen Plus HIV Ag-Ab references 72375 and 72376 .. This decision follows the possible instability of the conjugate R6 (polyclonal antibodies of sheep biotinylated anti-p24 HIV1) of the kit, resulting in positive HIV Ag control values ​​below the cut-off, thereby invalidating the assay series Previously, this possibility of instability led to the removal of lot 4L0575 on February 25, 200. .. This device is a kit for the detection of HIV infections in human serum / plasma by enzyme immunoassay technique. The company has directly notified the recipients of the incriminated batches by means of the attached message (24/06/2005 ) (17 ko) validated by Afssaps. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to patients. concerned.

Device

Genscreen Plus HIV Ag-Ab
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad