Events

Retiro De Equipo (Recall) de UNICEL DXC 600

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
    Recall
  • ID del evento
    53044
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-07-17
  • 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
    Beckman coulter has identified a failure of the unicel dxc ise tubing (lines 11 25 and 26) for ise reference reagent. the failure occurs due to the interaction between a new tubing plasticizer and the ise reference reagent. the supplier's change in plasticizer was a result of a move to a phthalate-free tubing material based on new environmental regulations. as a result a slowforming non-microbial white material may appear inside the tubing. observed symptoms of the presence of the white material can include suppressed ion specific electrode (ise) quality control and patient results ise calibration failures and detached tubing lines 25 or 26 due to obstruction of flow. current investigation suggests it is highly unlikely that incorrect results will be generated.

Device

UNICEL DXC 600
  • Modelo / Serial
    Model Catalog: 4764 (Lot serial: >10 numbers contact mfg.); Model Catalog: 4773 (Lot serial: 3048); Model Catalog: 4773 (Lot serial: 4282); Model Catalog: 4767 (Lot serial: >10 numbers contact mfg.); Model Catalog: 4771 (Lot serial: 4036); Model Catalog: 4768 (Lot serial: 4143); Model Catalog: 4768 (Lot serial: 2788); Model Catalog: 4768 (Lot serial: 3563)
  • Descripción del producto
    UniCel DxC 600 SYNCHRON Clinical Systems
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC