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
    43237
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2018-01-30
  • 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
    If the following sequence of events is followed it will result in sample mis-identification and erroneous results will be generated. the system will not identify or flag the erroneous results. - the stat button is selected within aquios cl software and the user opens the single-tube loader door. - user creates a test request when prompted places a specimen tube in single tube loader and closes the single-tube loader door. - the stat button is selected again and the user opens the single-tube loader door within 15 seconds or less of loading the first sample and before the "details" column on running screen changes to "prepping" for that sample. - user removes the first specimen tube and replaces with a different specimen tube. if another request is entered for the new specimen and the single-tube loader door is closed the new specimen tube will be prepared twice. both test requests will be processed with 2nd specimen tube. if another request is not entered for new specimen and the single-tube loader door is closed the new specimen tube will be prepared once. the first test request will be processed with 2nd specimen tube.

Device

AQUIOS CL FLOW CYTOMETER

Manufacturer

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