Events

Retiro De Equipo (Recall) de Remisol Advance

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Normand Informatique.

¿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
  • ID del evento
    78394
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0235-2018
  • Fecha de inicio del evento
    2017-10-16
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159406
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Causa
    Beckman coulter has identified that due to a software nonconformity in connection with a changed service setting remisol could display wrong results.
  • Acción
    Beckman Coulter sent an Urgent Medical Device Recall letter dated October 16, 2017, to all affected customers. Beckman Coulter has identified a potential issue due to a software nonconformity which could occur after a default service setting (NoCondition) is manually changed from off to on, potentially causing results outside of analytical range to be erroneously displayed. For further questions, please call (800) 526-3821.

Device

Remisol Advance
  • Modelo / Serial
    Version 1.6-1.9
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution and to the countries of : Australia, France, Germany, Israel and Russia
  • Descripción del producto
    Remisol Advance Software (Driver Architect) Catalog Number B32129 || The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing and data management (i.e. archiving and restoration of patient results). The Remisol Advance system also offers workstation consolidation to three Beckman Coulter instruments from a single user console.
  • Manufacturer
    Normand Informatique

Manufacturer

Normand Informatique
  • Dirección del fabricante
    Normand Informatique, Normand Informatique, Sci Git; 57 Grand place; Cs 10451, Arras CEDEX France
  • Source
    USFDA