Events

Retiro De Equipo (Recall) de Cobas c 501 / c 502 and COBAS INTEGRA. 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-00229-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-17
  • 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-00229-1
  • 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
    Following customer complaints regarding a 20% decrease in control levels when using third party controls (e.G. thermofisher liqimmune) roche has identified that reagent lot 697811 shows a negative bias of up to 54% compared to lot 604303.This negative bias could, in the worst case, lead to inaccurately low homocysteine results.This issue only occurs with edta plasma samples.
  • Acción
    Roche is requesting their customers to discard any remaining units from the affected lot. This action has been closed-out on 18/08/2016.

Device

Cobas c 501 / c 502 and COBAS INTEGRA. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Cobas c 501 / c 502 and COBAS INTEGRA. An in vitro diagnostic medical device (IVD)Material Number: 05 385 415 190Affected lots: 69781101Expiry Date: 30 Apr 2015Subsequent lots: 60717101Expiry Date: 31 Jan 2016
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited