Events

Retiro De Equipo (Recall) de UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

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
    53235
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-04-15
  • 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 the following issues with the unicel dxh 800 coulter cellular analysis system: 1.Auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old. 2.The last set of results for each panel analyzed without demographics will always be saved. 3.The dxh 800 may intermittently fail to transmit the correct control files or partially transmit the number of control files requested to the interlaboratory quality assurance program ("iqap") through the remote management system (rms). 4.The dxh 800 exports control data intended for interlaboratory quality assurance (iqap) in the reporting units configured by the customer. iqap is expecting to receive those results in one standard format.

Device

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
  • Modelo / Serial
    Model Catalog: 629029 (Lot serial: ALL)
  • Descripción del producto
    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
  • 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