Events

Retiro De Equipo (Recall) de Cobas 4800 BRAF V600 Mutation Test (acquired genetic alteration IVD). 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-00790-3
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2012-08-06
  • 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-00790-3
  • 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
    The test kit was assembled containing two components, the wt control and the mu control, that were released for non-commercial internal use only.
  • Acción
    Discontinue the use of affected product and dispose them appropriately. There is no requirement to re-test samples tested with the affected product. Roche will be supplying replacement stock when available.

Device

Cobas 4800 BRAF V600 Mutation Test (acquired genetic alteration IVD). An in vitro diagnostic medi...
  • Modelo / Serial
    Cobas 4800 BRAF V600 Mutation Test (acquired genetic alteration IVD). An in vitro diagnostic medical device (IVD)Material Number: 05985595190Lot Number: R03607ARTG Number: 192394
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited