Events

Retiro De Equipo (Recall) de OneTouch GlucoTouch Plus Blood Glucose Meters

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 LifeScan.

¿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
    2005-09-19
  • 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-lecteur-onetouch-r-glucotouch-r-plus-lifescan
  • 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
    In agreement with Afssaps, LifeScan is recalling OneTouch GlucoTouch Plus Blood Glucose Meters (L4266RBxxx Series to L5048RBxxx). Segments may be missing from the display and may result in an error in the reading of the result. Pharmacists in health facilities and / or pharmacies with these serial numbers should contact LifeScan on 0800 459 459 to inform them of the procedure to be followed. .. In addition, pharmacists are also asked to display in their dispensary the recall of devices mentioned and to inform users by means of the attached document (19/09/2005) (43 KB) which contains recommendations as well as the Verification of the display instructions. The relevant European Competent Authorities shall be informed directly by the manufacturer.

Device

OneTouch GlucoTouch Plus Blood Glucose Meters
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    LifeScan

Manufacturer

LifeScan