Events

Retiro De Equipo (Recall) de Alcohol Reagent (ETOH)

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
    2005-06-30
  • 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-reactif-alcool-etoh-beckman-coulter
  • 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 28, 2005, Beckman Coulter SA withdrew from the market batches M407255 and M409024 of the in vitro diagnostic medical device called Alcohol Reagent (ETOH) reference 474947 following possible quality control out of limits and calibration discharges before their expiry date. In addition, the expiry dates of lots M412090 and M503108 of the same device are shortened by four months. This device is used with the SYNCHRON LX, the UniCel 600/800 system (s) and the SYNCHRON Systems ETOH Calibrator. It is intended for the quantitative determination of ethanol in serum, plasma, human urine or human whole blood. The company has directly notified the recipients of the offending lots by means of the attached message (30 / 06/2005) (28 kb) validated by Afssaps. The competent European 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.

Device

Alcohol Reagent (ETOH)
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER