Events

Retiro De Equipo (Recall) de VITEK 2 System version 7.01. An in vitro diagnostic medical device (IVD).Bacteria identification and sensitivity system

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-2015-RN-00096-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-04
  • 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-00096-1
  • 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
    Biomeriuex has identified that the inoculum density range for the neisseria haemophilus (nh) identification (id) test card in the vitek 2 7.01 product information document (ref: 514740-1en1) is incorrect. in section 6 - procedure for nh card specimen preparation (step 3), the documented densichek plus inoculum density range is 1.80 - 2.20. the correct density range is 2.70 - 3.30.The incorrect information is located on the dvd software for the vitek 2 7.01 system. all other product documentation has the correct inoculum density.
  • Acción
    bioMerieux is advising end users of the incorrect inoculum density range and requesting that the recall letter be kept with the instrument documentation. bioMerieux will update the VITEK 2 7.01 Product Information to include the correct DensiCHEK inoculation concentration. This action has been closed-out on 09/08/2016.

Device

VITEK 2 System version 7.01. An in vitro diagnostic medical device (IVD).Bacteria identification ...
  • Modelo / Serial
    VITEK 2 System version 7.01. An in vitro diagnostic medical device (IVD).Bacteria identification and sensitivity system
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd