Retiro De Equipo (Recall) de Vancomycin 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 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
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  • 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 4 April 2006, Beckman Coulter France withdrew lots M507219 (per 31/10/2007) and M511327 (per 31/12/2007) from the market for in vitro diagnostic medical device called Vancomycin reagent reference 474824 continued the evidence of instability in these batches, which could lead to an underestimation of about 15% of the quality control and patient results. This device is used for the quantitative determination of the concentration of Vancomycin in human serum or plasma with SYNCHRON LX and UniCel DxC systems. The company has directly notified the recipients of the offending lots by means of the attached message (06 / 04/2006) (82 KB) validated by Afssaps. The European Competent Authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.


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