Retiro De Equipo (Recall) de Remisol Advance Software Versions 1.6-1.9, Architect Driver

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Beckman Coulter Australia Pty Ltd.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    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. please note that the “nocondition” setting is not customer configurable through any instructions, but is reserved for field service configuration. if both conditions occur at the same time, i.E. the changed setting and a result outside of analytical range, an incorrect result could potentially be reported to the physician.
  • Acción
    Beckman Coutler is advising users to check device settings as directed in the letter supplied to customers. If the setting is correct there is no further action required. If the setting is NOT correct, users should contact their local Beckman Coulter representative immediately, and either: (1) discontinue use of Remisol with the Architect instrument; or (2) monitor results sent from the Architect instrument to Remisol to ensure Remisol does not receive results outside the dynamic range from the Architect instrument.