Events

Retiro De Equipo (Recall) de VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses the matrix-assisted laser desorption / ionization (MALDI) mass spectrometry method) (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 Biomerieux Australia 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-2013-RN-01051-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-11
  • 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-2013-RN-01051-1
  • 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
    Some issues have been reported when firmware version 3.13 was installed on systems equipped with the old transient recorder (tr) board (ref. 6200350). extensive testing has proven that firmware 3.13 may potentially cause an instrument to freeze or hang during acquisition when installed with the old tr board, with a risk of repeated results for different spots. this issue does not occur if firmware version 3.13 is installed with the new tr board ae8679ad (ref. 6200720).
  • Acción
    Biomerieux is requesting users to reboot the instrument if the board freezes. Biomerieux is advising users that the new TR board is required to have firmware V3.13, and the old TR board is required to have firmware version V3.10. Biomerieux is contacting users to migrate the firmware if required.

Device

VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses t...
  • Modelo / Serial
    VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses the matrix-assisted laser desorption / ionization (MALDI) mass spectrometry method) (an in vitro diagnostic medical device (IVD))Catalogue Number: 410895Serial Numbers: Lower than #50039, #50050, greater than or equal to #60000ARTG Number: 199422
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd