Retiro De Equipo (Recall) de Coulter Clenz®

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 BECKMAN COULTER.

¿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
  • Fecha
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  • Fuente del evento
  • URL de la fuente del evento
  • 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 11 October 2005, Beckman Coulter France SA withdrew from the market lots 30881 (per 20/05/2006), 30916 (per 08/06/2006), 30940 (per 28/06/2006) and 30941 (dated 28/06/2006) of the in vitro diagnostic medical device called Coulter Clenz® reference 8448222 following the detection of microbiological contamination on a limited number of containers resulting in high residual counts for platelets and platelets. Reticulocytes .. This device is a cleaning agent for automated hematology .. The company has directly notified the recipients of the offending lots by means of the message attached (13/10/2005) (24 KB) validated by the AFSSAPS .. The relevant European Competent Authorities 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. born.


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