Events

Retiro De Equipo (Recall) de Flex® C-Reactive High Sensitivity Protein Cartridge (RCRP)

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
    2005-06-09
  • 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-behring2
  • 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 6, 2005, Dade Behring removed the lots from the market. CF5285 (12/10/2005). EJ5294 (21/10/2005). EG5300 (per 27/10/2005). CJ5336 (02/12/2005). EF5306 (02/11/2005). BP5316 (12/11/2005). BA5326 (02/11/2005). DH5341 (07/12/2005). DE5348 (14/12/2005). FJ5356 (22/12/2005) ,. of 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 with the consequence of an inability to calibrate the method, either results with error messages, or imprecision or random accuracy of patient results and quality controls. This device is used for the quantitative determination of C-reactive protein in serum and heparinized plasma. on the Dimension® clinical chemistry system .. The company has directly notified the recipients of the offending lots by means of the enclosed message (06/06/2005) (13 KB) validated by Afssaps. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, directors of health correspondents of reactive vigilance for dissemination, where appropriate, to the services concerned.

Device

Flex® C-Reactive High Sensitivity Protein Cartridge (RCRP)
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING

Manufacturer

DADE BEHRING
  • Source
    LAANSM