Events

Retiro De Equipo (Recall) de AQUIOS CL FLOW CYTOMETER

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
    49649
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2017-10-02
  • 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
    When aquios cl systems are connected to a laboratory information system (lis) the system may duplicate sample requests leading to sample mis-identification. for this to happen the following conditions must be met: -the aquios cl flow cytometer is connected to an lis and -the aquios cl system has the default test enabled and -host query is enabled in lis setup screen on system and -there are multiple cassettes in the autoloader and -the lis host query response is received in a brief time window before lis response timeout occurs. when all of these conditions are met a sample will follow two (2) paths of test request creation (lis and default test). all software versions (2.0 2.0.1 and 2.1) in existence are impacted by this issue and all applications used on the aquios cl are impacted by this issue.

Device

AQUIOS CL FLOW CYTOMETER

Manufacturer

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