Events

Retiro De Equipo (Recall) de VIDAS SYSTEM - ANALYZER CLASS 3

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BIOMERIEUX 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
    34048
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-01-10
  • 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
    An anomaly with the aspiration or dispensing steps performed by the pump (particularly due to pump clogging) may impact the volume of patient sample pipetted or the other solutions transferred into the strip wells. as a volume decrease could induce an impact on the biological test result the quality control vidas (qcv) test has been designed to detect pump issues and alert the user before a biological test result is affected. qcv frequency and threshold alert have been defined to enable the system to detect progressive clogging.

Device

VIDAS SYSTEM - ANALYZER CLASS 3
  • Modelo / Serial
    Model Catalog: W2205 (Lot serial: all); Model Catalog: 99735 (Lot serial: all); Model Catalog: REF. 410416 (Lot serial: all); Model Catalog: 410416 (Lot serial: all); Model Catalog: 99737 (Lot serial: all); Model Catalog: 99733 (Lot serial: all)
  • Descripción del producto
    VIDAS SYSTEM - ANALYZER CLASS 3;MINIVIDAS ANALYZER
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.