Events

Retiro De Equipo (Recall) de Tina-quant Albumin. 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-01103-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-11-11
  • 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-01103-1
  • 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
    Roche diagnostics is recalling one lot of tina-quant albumin (used for the determination of specific proteins in samples) following advice that it may show an elevated qc recovery outside of specification when used on the modular p analyser.This phenomenon is only noted when using roche qc precinorm puc (material number 03121313122).
  • Acción
    Roche is advising users to inspect stock and discard all units of the affected lot number. Affected stock will be replaced by alternative lots which are unaffected by this issue. This action has been closed-out on 29/08/2016.

Device

Tina-quant Albumin. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Tina-quant Albumin. An in vitro diagnostic medical device (IVD)Material Number: 04999622190Lot Number: 60221401ARTG Number: 174908
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited