Events

Retiro De Equipo (Recall) de Cobas EGFR MutationTest Kit(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-2015-RN-00091-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-06
  • 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-2015-RN-00091-1
  • 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
    The cobas egfr mutationtest, lot t08661 is generating false positive results for exon 20 insertion mutations (i.E., false mutation detected results). this mutation is typically only observed in 1-4% of the population depending on the geographic region. the issue is currently under investigation by roche. no other lots or pack sizes of this product are affected by this recall.
  • Acción
    Roche Diagnostics Australia is requesting the customers to review their stocks, discontinue use and discard all remaining units of the above lot number. Roche Diagnostics Australia is providing replacement kits to the customers. This action has been closed-out on 15/08/2016.

Device

Cobas EGFR MutationTest Kit(An in vitro diagnostic medical device (IVD))
  • Modelo / Serial
    Cobas EGFR MutationTest Kit(An in vitro diagnostic medical device (IVD))Catalogue Number: 06471463190Lot Number: T08661ARTG number: 194319
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited