Events

Retiro De Equipo (Recall) de VIDAS 3 System (used with software version 1.1.4) 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-2017-RN-00331-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-03-14
  • 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-00331-1
  • 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
    Software anomalies have been discovered in the vidas 3 software version 1.1.4. the following are the limitations that could impact the system:1. the “error code 0550capu1” posted in case of tip lost does not suggest the appropriate troubleshooting 2. for customers using automatic pipetting mode: non-justified “error code 0400fapu1”3. stop section during analytical phase can induce drop on the strip or into the instrument4. for customers managing their internal/external quality control via quality control module of vidas 3 only5. for countries applying winter time change only.
  • Acción
    bioMérieux is advising users to apply the required actions associated with the relevant limitation (as described in the customer letter). Users are further advised to discuss concerns about previously reported results with their Laboratory Medical Director to determine the appropriate course of action.

Device

VIDAS 3 System (used with software version 1.1.4) An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VIDAS 3 System (used with software version 1.1.4) An in vitro diagnostic medical device (IVD)Catalogue Number: 412590ARTG Number: 199422
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd