Events

Retiro De Equipo (Recall) de BacT/ALERT 3D B.40.xx Firmware (Automated blood culture incubator/growth detector). 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-2012-RN-01071-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-22
  • 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-2012-RN-01071-1
  • 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
    An improper load occurs when the user performs another action (such as loading a bottle or scanning another bottle) before the reply beeps have been issued. an improper load results in the first bottle not being recognised as being loaded in the instrument and the second bottle's readings being incorrectly reported in association with the first bottle.
  • Acción
    Affected laboratories are to implement the corrected User Manual provided by the Sponsor.

Device

BacT/ALERT 3D B.40.xx Firmware (Automated blood culture incubator/growth detector). An in vitro d...
  • Modelo / Serial
    BacT/ALERT 3D B.40.xx Firmware (Automated blood culture incubator/growth detector). An in vitro diagnostic medical device (IVD)Product code: 411814 or 411818
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd