Events

Retiro De Equipo (Recall) de BD FACSCANTO FLOW CYTOMETER - 7-COLOUR BEADS

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
    135963
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-07-11
  • 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 facs 7-color setup bead kit is shipped with a cd containing pass/fail values for the cytometer sensitivity test (part of cytometer qc). the incorrect version of the cd was included with bd facs 7-color setup beads (cat. no. 335775 lot no. 33412). the kit should have cd version 3.0 instead of 2.0. kit lot 33412 (part of "pl8" batches) was shipped with a cd containing pass/fail values for a different lot which was part of the "pl6" batches. the recall is specific only to the cd within the kit. the 7-color setup beads are not affected. bd is not requesting that the 7-color setup beads be destroyed.

Device

BD FACSCANTO FLOW CYTOMETER - 7-COLOUR BEADS
  • Modelo / Serial
    Model Catalog: 335775 (Lot serial: 33412)
  • Descripción del producto
    BD FACS 7-Color Setup Beads
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.