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
    104121
  • 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 reader assembly is the optics component of the instrument that translates pcr amplification into curves for an algorithm or user to interpret results. if the filter/lens pair inside the reader assembly becomes loose the readers can produce curves with excess variability - the curve may appear shaky or oscillatory around expected curve. the issue originates in manufacture and does not get worse over time. when using the instrument for ivd assays there is the potential for false positive results. when using the instrument for open system assays the issue is not expected to cause false results because the instrument produces the curve but does not interpret the curve (i.E. the curve for open system assays is to be interpreted by the user not the instrument algorithms). assay development by the user would have incorporated any [consistent-overtime] curve abnormalities.

Device

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

Manufacturer

BECTON DICKINSON CANADA INC.