Events

Retiro De Equipo (Recall) de cobas 8100 BRF and URF with software versions 02-xx. 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-2017-RN-00373-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-22
  • 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-2017-RN-00373-1
  • 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
    An issue regarding the reformatter modules urf and brf of the cobas 8100 automated workflow series (when used with software version 02-xx) has been identified. this issue is caused by an incorrect mechanical control sequence based on a limitation in software versions 02-xx, resulting in the racks to be shaken and specimen spillage. sample spillage may cause cross contamination of samples and potentially expose operators to infectious material.
  • Acción
    Until the installation of the software upgrade, Roche Diagnostics is advising users to ensure that the rack buffering function is disabled in the configuration of the Control Unit. In the event of a major spillage, users are advised to set the affected modules offline. These modules should be checked and cleaned by a Roche Service Representative before being returned to routine operation. This action has been closed-out on 15/03/2018.

Device

cobas 8100 BRF and URF with software versions 02-xx. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    cobas 8100 BRF and URF with software versions 02-xx. An in vitro diagnostic medical device (IVD)cobas 8100 automated workflow seriesBRF for cobas 8100Material Number: 07439954001URF for cobas 8100Material Number: 07441657001ARTG Number: 173887
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited