Events

Retiro De Equipo (Recall) de cobas IT 1000, version 2.00.00.02 to current, ESX 4.1 platform virtual server (Analyser software). 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-01299-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-24
  • 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-01299-1
  • 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 issue regarding the date of birth demographic in it 1000 when a change in timezone is made on the it 1000 server. if the user enters a patient date of birth manually in "results & results>single patient edit", the cobas it 1000 application may save an earlier date instead, the most common example being that the date of birth is listed as the day prior. for example; a patient date of birth is entered as 01-nov-1931 and is saved as 31-oct-1931.
  • Acción
    Roche is providing work around instructions for users to implement.

Device

cobas IT 1000, version 2.00.00.02 to current, ESX 4.1 platform virtual server (Analyser software)...
  • Modelo / Serial
    cobas IT 1000, version 2.00.00.02 to current, ESX 4.1 platform virtual server (Analyser software). An in vitro diagnostic medical device (IVD)ARTG Number: 174914
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited