Events

Retiro De Equipo (Recall) de PREPSTAIN - SLIDE PROCESSOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECTON DICKINSON CANADA 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
    Recall
  • ID del evento
    56247
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-09-04
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    A software issue which may affect bd prepstain slide processors running one of the following software versions: - gyn 1.2 and non-gyn 2.80 - gyn 1.3.0.1 and non-gyn 2.80 rack layout data for software version non-gyn 2.80 are incorrectly reset when gyn software version gyn 1.2 or 1.3.0.1 are subsequently installed on the system. this will result in a loss of chain of custody for non-gynecological samples. when the issue occurs the first 12 samples are not processed at all and all others (up to 36 per run) are deposited on the wrong slide. the risk is highest for customers who have software version gyn 1.3.0.1 (released in june 2008). it is also possible that the issue could occur with software version gyn 1.2 (released in october 2005). there is no impact to gynecological specimen processing (pap tests). in september 2008 all customers using the bd prepstain slide processor were made aware of this software issue and informed that the error may have potentially resulted in mismatched patient results. a process was initiated and is still ongoing to upgrade software for affected customers. bd-canada field service personnel will be upgrading (or have already upgraded) all bd prepstain slide processors to unaffected software versions (gyn 1.3.0.2 or gyn 1.3.0.3).

Device

PREPSTAIN - SLIDE PROCESSOR
  • Modelo / Serial
    Model Catalog: 799-13000-00 (Lot serial: All); Model Catalog: 799-14000-00 (Lot serial: All); Model Catalog: 490407 (Lot serial: All)
  • Descripción del producto
    BD PrepStain Slide Processor
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.