Retiro De Equipo (Recall) de BD FocalPoint"

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Tripath Imaging, Inc..

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Processor, cervical cytology slide, automated - Product Code MKQ
  • Causa
    The cable tie mounts that adhere to the inside of the focalpoint do not adhere as intended and can therefore become detached.
  • Acción
    BD Diagnostics first notified consignees by letter on October 6, 2011. BD Diagnostics also sent a letter dated February 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Field Representatives were advised to inspect all cables, adhesive cable ties and connections to ensure they are secure. Inspections and repairs, if necessary, would be carried out at the next service call for each instrument, or no later than the next regularly scheduled preventative maintenance visit. For questions consignees were instructed to contact BD Diagnostics Technical Support at 1-877-822-7771 option 2 in the US, their local distributor, or their local BD office for any questions. For questions regarding this recall call 918-563-1624.


  • Modelo / Serial
    To be obtained
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
  • Descripción del producto
    BD Focal Point"230V LC (Refurbished), Catalog number: 490681. || The BD Focal Point" Slide Profiler (formerly the AutoPap¿¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
  • Manufacturer


  • Dirección del fabricante
    Tripath Imaging, Inc., 780 Plantation Dr, Burlington NC 27215-6723
  • Empresa matriz del fabricante (2017)
  • Source