Events

Retiro De Equipo (Recall) de cobas 4800 - z 480 (Real time PCR sample preparation, amplification and detection instrument). 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-00278-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-03-28
  • 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-00278-1
  • 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
    Roche has advised that in rare instanced channel shifted results have been generated with cobas 4800 assays run on v1.X software of the cobas 4800 system. raw data review indicates that in these cases, all signals are shifted by one channel:- channel 1 results report as channel 2- channel 2 results report as channel 3- channel 3 results report as channel 4- channel 4 results report as channel 1. in the reported cases the results of the runs were either invalid or the preponderance of individual patient specimen showed to be invalid.
  • Acción
    Roche is providing end users with work around instructions to mitigate the issue. A software update to detect and mitigate the issue will be implemented in late 2013. This action has been closed-out on 28/01/2016

Device

cobas 4800 - z 480 (Real time PCR sample preparation, amplification and detection instrument). An...
  • Modelo / Serial
    cobas 4800 - z 480 (Real time PCR sample preparation, amplification and detection instrument). An in vitro diagnostic medical device (IVD).All serial numbers affected
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited