Events

Retiro De Equipo (Recall) de Radiometer AQT90FLEX Immunoassay analyser. 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 Radiometer Pacific Pty Ltd.

¿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-2017-RN-01195-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-14
  • 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-2017-RN-01195-1
  • 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
    Radiometer has recently become aware that the internal temperature in the aqt90 flex analyser under worst case conditions may slightly exceed acceptable storage conditions for aqt90 flex on-board test cartridges.Please note that if the aqt90 is exposed to temperatures above the new limit, but still within the old limits, the cartridges are still safe to use. the specifications are only affected with a few % and this is below any clinical significance. no action is required regarding the cartridge.To ensure that the temperature does not exceed maximum limit, the environmental specifications for the ambient temperature for the aqt90 flex analyser has been adjusted to 30°c/86.0°f (down from 32°c/89.6°f).
  • Acción
    1. To ensure that the temperature does not exceed maximum limit, the environmental specifications for the ambient temperature for the AQT90 FLEX Analyser has been adjusted to 30°C (down from 32°C). 2. For users: a. If the ambient temperature is above 30°C r reduce it to below 30°C or move the analyser to another location that is below 30°C b.Complete and return the supplied Customer Reply form, within 7 days from receipt, to acknowledge this notification and implementation of the required actions. c. If you are not the end user of the affected product please ensure that this letter is distributed to the final end user. 3. Radiometer will contact users to arrange a suitable time for a Radiometer representative to install a software upgrade V8.9.613.0 or higher. This software upgrade will reduce the heat generated internally and distribute the heat generated more evenly. 4. Users will also be provided with a revised copy of the Instructions For Use (IFU).

Device

Radiometer AQT90FLEX Immunoassay analyser. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Radiometer AQT90FLEX Immunoassay analyser. An in vitro diagnostic medical device (IVD)All Serial NumbersARTG Number: 224867
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd