Events

Retiro De Equipo (Recall) de Calibrant Urinary Protein

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
    Recall
  • Fecha
    2006-04-13
  • 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-d-un-lot-du-dmdiv-calibrant-proteines-urinaires-beckman-coulter-france
  • 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 April 11, 2006, Beckman Coulter France withdrew from the market lot M411138 (31/08/2006) of the in vitro diagnostic medical device called Calibrant Urinary Protein reference 441470 following the detection of an instability of the analyte alpha 1 microglobulin may be the cause, after calibration, an overestimation on the parameter alpha 1 microglobulin results of quality control and patient samples. This calibrator is used on the IMMAGE and ARRAY systems. The company has directly notified the recipients of the offending batch by means of the attached message (11/04/2006) (72 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of establishments health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

Calibrant Urinary Protein
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER