Events

Retiro De Equipo (Recall) de Roche Diagnostics Cobas c501/502 XN-9000

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Roche Diagnostics GmbH.

¿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
    20984
  • Fecha de inicio del evento
    2016-12-23
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    The manufacturer has been notified of a software bug identified on the xn-9000 line products in which patient information was replaced by that of another patient resulting in incorrect patient demographics being assigned to the patient sample and the results reported.
  • Acción
    Instructions for use to be updated

Device

Roche Diagnostics Cobas c501/502 XN-9000
  • Modelo / Serial
    Model: , Affected: XN-9000 complete with XN-10/20 on Version 20 Build 8
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH