Events

Retiro De Equipo (Recall) de PROCOUNT PROGENITOR CELL ENUMERATION KIT

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
    20000
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-06-30
  • 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
    Pouches contained in the kit lot 6083708 may not be sealed properly. the pouches contained in the kit can be identified with the lot no.16040 and are embossed with "17 02 16 t3" or "16 02 16 t3". improper storage of trucount tubes due to failed pouch closure can affect the performance of the counting beads leading to erroneous results in enumeration assays utilizing trucount. if the pouch seal is intact and the desiccant included in the pouch is blue the product may be used. if the pouch seal integrity is compromised and/or the desiccant has turned from blue to lavender discard the tubes because exposure to the ambient environment can rapidly degrade the performance of the product.

Device

PROCOUNT PROGENITOR CELL ENUMERATION KIT
  • Modelo / Serial
    Model Catalog: 340334 (Lot serial: 6083708)
  • Descripción del producto
    BD Trucount tubes
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.