Events

Retiro De Equipo (Recall) de COBAS INTEGRA 800 Software Version 9864.C2. An in vitro diagnostic medical device (IVD).

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

¿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
    RC-2013-RN-00926-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-09-04
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00926-1
  • 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
    A software bug has been detected in the cobas integra 800 software version 9864.C2 which affects the execution of routine maintenance of the ise module. the issue is caused by the ise counters in the software being reset to zero whenever the ise rack is removed from the analyser. lf ise service actions and manual maintenance items are not executed at their recommended intervals, there is a potential risk of increased occurrence of calibration flags (slope, sol i dev etc), as well as incorrect and unflagged ise results.
  • Acción
    Roche is currently working on a software fix expected to be implemented by the end of the year. Until the software is available, Roche recommends that operators manually track all ISE counters and to manually request the corresponding Service Action in the Service Software.

Device

COBAS INTEGRA 800 Software Version 9864.C2. An in vitro diagnostic medical device (IVD).

Manufacturer

Roche Diagnostics Australia Pty Limited