Events

Retiro De Equipo (Recall) de Synchron EL-ISE PLCs

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
    2005-06-01
  • 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-embouts-d-electrodes-de-potassium-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 30/05/05, Beckman Coulter SA withdrew from the market batches 0446 to 0508 of the in vitro diagnostic medical device called potassium electrode tips used on Synchron EL-ISE PLCs (references 445604 or 441104) and on Synchron CX / LX and UniCel DXC controllers (references 669117 or 668281) due to the fact that they can not be calibrated. In addition, batches 0512 and above do not show the stability duration of the 24-hour calibration announced with a risk of drifting upwards. The recipients of these batches have therefore been warned of the action to be taken. This device is used for the determination of potassium in the blood. Beckman Coulter SA has directly informed the recipients of the incriminated batches by means of the attached messages. (01/06/2005) (77 ko) validated by the 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.

Device

Synchron EL-ISE PLCs
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER