Events

Retiro De Equipo (Recall) de BD MAX (6 channel) Instruments (Automated specimen preparation and PCR amplification/detection instrument). 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 Becton Dickinson 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-00995-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-09-26
  • 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-00995-1
  • 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
    Bd has determined that the bd max instrument may have minor defects that could cause the instrument to malfunction yet is unlikely to cause erroneous results. the minor defect(s) may be due to the following:1) a potential misalignment of the filters/lens in the reader assembly that can produce reaction curves with excess variability2) a supplier defect on a limited number of mux heater board assemblies.
  • Acción
    Becton Dickinson Service Associate to inspect the instrument and perform corrections if required

Device

BD MAX (6 channel) Instruments (Automated specimen preparation and PCR amplification/detection in...
  • Modelo / Serial
    BD MAX (6 channel) Instruments (Automated specimen preparation and PCR amplification/detection instrument). An in-vitro diagnostic medical device (IVD)Catalogue Number: 441916Serial Numbers: CM0053 and CM0105
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd