Events

Retiro De Equipo (Recall) de Cobas IT 3000 version 2.03.04 to 2.04.00, Cobas 8000 Data Manager version 1.02.02 to 1.02.05, Cobas INTEGRA 400 and Cobas INTEGRA 400 Plus. In vitro diagnostic medical devices (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-01095-1
  • 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-01095-1
  • 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
    There is a potential security vulnerability with the oracle tns-listener component due to an insecure default configuration. the tns-listener is part of the software roche supplied with the above mentioned products. the vulnerability may allow attackers to modify the content of a database from aremote system if the roche products are located on a network with insufficient security to prevent unauthenticated access. oracle has issued a security alert entitled "cve-2012-1675 oracle tns listener poisoning".

Device

Cobas IT 3000 version 2.03.04 to 2.04.00, Cobas 8000 Data Manager version 1.02.02 to 1.02.05, Cob...
  • Modelo / Serial
    Cobas IT 3000 version 2.03.04 to 2.04.00, Cobas 8000 Data Manager version 1.02.02 to 1.02.05, Cobas INTEGRA 400 and Cobas INTEGRA 400 Plus. In vitro diagnostic medical devices (IVD).
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited