Events

Retiro De Equipo (Recall) de Cobas 8000 Patient sample and control recovery on Cobas c 701/702 modules (clinical chemistry analyser). 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-2012-RN-01113-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-01
  • 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-2012-RN-01113-1
  • 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 on the cobas 8000, cobas c 701/702 modules, which under certain conditions can lead to a mismatch between reagent probe positioning during pipetting and the aspirate sample volumes, leading to possible incorrect results. until the new software version is available, roche have updated the application e-barcodes for the affected assays, which reduce the number of available tests.
  • Acción
    Roche will be providing work around instructions to mitigate the risk and will be providing a software update to permanently correct the issue.

Device

Cobas 8000 Patient sample and control recovery on Cobas c 701/702 modules (clinical chemistry ana...
  • Modelo / Serial
    Cobas 8000 Patient sample and control recovery on Cobas c 701/702 modules (clinical chemistry analyser). An in vitro diagnostic medical device (IVD)Multiple affected assays
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited