Events

Retiro De Equipo (Recall) de Slidex Strepto-Kit

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 BIOMERIEUX.

¿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
    2006-03-06
  • 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-des-dmdiv-slidex-strepto-kit-slidex-strepto-b-et-slidex-strepto-d-biomerieux
  • 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 March 2, 2006, bioMérieux removed from the market In Vitro Medical Diagnostic Devices called:. Slidex Strepto-Kit - reference 58810 - lots 50822 (per 30/08/2006), B 50822 (per 30/08/2006), 50924 (per 04/10/2006). Slidex Strepto B - reference 58816 - lots 50913 (per 08/09/2006), 51035 (per 07/11/2006). Slidex Strepto D - reference 58817 - lots 50920 (06/10/2006) .. These devices are latex particle agglutination tests for rapid grouping of beta-hemolytic streptococci A, B, C, D, F and Lancefield's G .. This measure follows the discovery of a decrease in the sensitivity of the latexes that may be at the origin of non-identification of a group B, D or F beta-hemolytic streptococcus. The company has directly notified the recipients of the offending lots by means of the enclosed message (01/03/2006) (15 KB) validated by Afssaps. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Slidex Strepto-Kit
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX