Events

Retiro De Equipo (Recall) de Human anti-Fyb reagent

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 Diamed.

¿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
    2005-08-01
  • 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-reactif-anti-fy-b-humain-diamed
  • 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 28 July 2005, the company DIAMED withdrew from the market the lots 19310.50.10 (per 31/07/2006), 19310.50.20 (per.31 / 07/2006) and 19310.51.10 (31/01/2007) of the in vitro diagnostic medical device called human anti-Fyb reagent reference 103901 following the demonstration of a weakening of reactivity. This device is a human test anti-FyB serum, for antiglobulin tube test .. The company has directly notified the recipients of the incriminated lots by means of the message attached (28/07/2005) (11 KB) validated by the Afssaps .. The competent European authorities concerned are informed by the Swissmedic industrialist and the competent Swiss authorities. This information is intended for laboratory managers, directors of health establishments and correspond- io-vigilance correspondents for dissemination. where appropriate, to the services concerned.

Device

Human anti-Fyb reagent
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Diamed

Manufacturer

Diamed
  • Source
    LAANSM