Retiro De Equipo (Recall) de DURACLONE B27 REAGENT KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECKMAN COULTER CANADA L.P..

¿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
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    Beckman coulter has identified that the reagent lot identified above was inadvertently released to market despite not meeting its full product specification. the hla-b27 median fluorescence intensity (mdfi) of this lot is higher than lots meeting the product specification which may lead to: (1) an indicated result in the indeterminate zone when the true result is in the negative range or (2) an indicated result in the positive range when the true result is in the indeterminate zone. the issue was discovered on 2016 march 21 during periodic review of our batch records. there has been no report of death or injury related to this defect.


  • Modelo / Serial
    Model Catalog: B36862 (Lot serial: 210116)
  • Descripción del producto
  • Manufacturer


  • Dirección del fabricante
  • Empresa matriz del fabricante (2017)
  • Source