Events

Retiro De Equipo (Recall) de Pathfinder® Virus Herpes Simplex Types 1 and 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 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
    2005-12-02
  • 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-d-un-lot-du-dmdiv-pathfinder-r-virus-herpes-simplex-types-1-et-2-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    On 30/11/2005, the company BIO-RAD has withdrawn lot 930848 from the in vitro diagnostic medical device called Pathfinder® Virus Herpes Simplex Types 1 and 2 reference 25215. This device is used for the direct fluorescence test used to identify and typify herpes simplex virus in direct clinical specimens and cell culture isolates. This follows the finding of a few anti-HSV1 monoclonal antibody vials in this lot. may cause a decrease in fluorescence controls and patient samples .. The company has directly notified the recipients of the offending batch by means of the attached message (30/11/2005) (11 KB) validated by Afssaps. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Pathfinder® Virus Herpes Simplex Types 1 and 2
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad