Events

Retiro De Equipo (Recall) de ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD

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
    146351
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-03-05
  • 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 determined that there is a potential for incorrect settings to be installed on north american ichemvelocity urine chemistry analyzers. - the installation of international settings can result in the generation of erroneous false low results for some of the analytes at some concentrations. - the installation of colors different from those stated in the instructions for use (colorless straw yellow amber red blue) for output settings will result in incorrect reporting of colors. for example if green is the color choice for the output setting instead of blue green will be reported.

Device

ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD
  • Modelo / Serial
    Model Catalog: 800-7167 (Lot serial: ALL); Model Catalog: 800-7714 (Lot serial: ALL); Model Catalog: 800-7713 (Lot serial: ALL); Model Catalog: 800-3079 (Lot serial: ALL); Model Catalog: 800-7720 (Lot serial: ALL); Model Catalog: 800-3049 (Lot serial: ALL); Model Catalog: 800-7719 (Lot serial: ALL); Model Catalog: 800-7715 (Lot serial: ALL); Model Catalog: 800-3080 (Lot serial: ALL); Model Catalog: 800-3050 (Lot serial: ALL)
  • Descripción del producto
    ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD;IRICELL 2000 PLUS;IRICELL 3000 PLUS;ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM BACK INTEGRATED;IRICELL 2000 PRO;ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM;IRICELL 1000 PLUS;IRICELL 30
  • 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