Events

Retiro De Equipo (Recall) de Flex® RCRP reagent cartridge

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 DADE BEHRING.

¿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
    2005-11-24
  • 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-cartouche-de-reactifs-flex-r-rcrp-dade-behring
  • 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 November 22, 2005, Dade Behring withdrew lots BC6122 (2/05/06), BD6123 (3/05/06), CC6130 (10/05/06), CD6192 (11/07/06) , DB6199 (18/07/06), FG6209 (28/07/06), EF6229 (17/08/06), of the in vitro diagnostic medical device called Flex® C-Reactive High Sensitivity Protein Cartridge (RCRP) reference DF34. This decision follows the identification of a stability problem that results in either an inability to calibrate the method, or results with error messages, or a inaccurate inaccuracy or inaccuracy of the patient results and controls. quality. This device is used for the quantitative determination of the C-Reactive Protein in serum and heparin plasma on the Dimension® clinical chemistry system. The company has directly notified the recipients of the offending lots by means of the attached message (24/11/2005) (14 KB) validated by Afssaps. The relevant European Competent Authorities will be informed by the competent UK authority which has This information is addressed to the laboratory managers, the directors of the health establishments and the reactovigilance correspondents for distribution, if necessary, to the services concerned.

Device

Flex® RCRP reagent cartridge
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING

Manufacturer

DADE BEHRING
  • Source
    LAANSM