Events

Retiro De Equipo (Recall) de iChemVELOCITY Urine Chemistry Analyzers

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Beckman Coulter Inc.

¿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
    22701
  • Fecha de inicio del evento
    2018-03-08
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Causa
    The manufacturer 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 colours differ from those stated in the instructions for use (colourless, straw, yellow, amber, red, blue) for output settings will result in incorrect reporting of colours. for example, if green is the colour choice for the output setting instead of blue, green will be reported.
  • Acción
    Software to be upgraded

Device

iChemVELOCITY Urine Chemistry Analyzers
  • Modelo / Serial
    Model: , Affected: All Instruments with North America System Configuration Settings
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc