Events

Retiro De Equipo (Recall) de BD MAX SYSTEM

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
    122036
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-07-29
  • 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
    The bd max system is capable of automated extraction and purification of nucleic acids from multiple specimen types and is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical industrial and research settings. the instrument has both "open system" and ivd functionality. there are two issues concerning the heater and the reader. these issues are being treated by health canada as separate recalls and therefore at the request of health canada a separate notice has been prepared for each. the heater is part of an assembly that controls thermal cycling during polymerase chain reaction (pcr) and opening of the wax valves in the consumable [pcr] cartridge. individual heaters may fail to reach target temperatures if a defect ("shunt") is present. the magnitude of the potential temperature error is as high as 10 c lower than expected however most estimates are near 2 c lower than normal (instrument spec is temperature +/- 2 c). there is the potential for false negative results.

Device

BD MAX SYSTEM
  • Modelo / Serial
    Model Catalog: 441916 (Lot serial: CM0094); Model Catalog: 441916 (Lot serial: CM0006)
  • Descripción del producto
    BD MAX Instrument
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.