Events

Retiro De Equipo (Recall) de VIDAS and mini VIDAS systemsIn vitro diagnostic medical devicesIn combination with Quality Control VIDAS (QCV)

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-2018-RN-00060-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-13
  • 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-2018-RN-00060-1
  • 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
    A review of relevant data and feedback from users has identified there are some pump clogging and displacement of the colour coded label. the pump clogging could contribute to erroneous results for any assay performed on the vidas and mini vidas system due to decrease of pipetted volume.
  • Acción
    bioMérieux is advising users to implement the following permanent changes in managing the affected systems: 1. Increase the frequency of the QCV testing to weekly rather than monthly to reduce the period of potential retrospective analyses needed. In the event of QCV test fail, it is recommended to review previous results with the laboratory medical director, and perform a retrospective analysis of all patient specimens processed since the last successful QCV test. bioMérieux will update the User Manual to reflect this requirement 2. As indicated within the Instructions For Use, continue to conduct a visual inspection of the SPR after each run (including patient sample test and QCV test) to ensure that the dot on the SPR is still in place In response, bioMérieux is taking action to help ensure the instruments perform as intended: 1. Pumps have to be changed every 7 years 2. bioMérieux will systematically clean the VIDAS/mini VIDAS pumps during the yearly Preventive Maintenance

Device

VIDAS and mini VIDAS systemsIn vitro diagnostic medical devicesIn combination with Quality Contro...
  • Modelo / Serial
    VIDAS and mini VIDAS systemsIn vitro diagnostic medical devicesIn combination with Quality Control VIDAS (QCV) (ARTG: 203664)Multiple Affected Reference NumbersARTG Number: 199422 Biomerieux Australia Pty Ltd - Instrument/analyser IVDs
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd