Events

Retiro De Equipo (Recall) de Iris iChem Velocity Automated Urine Chemistry System

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 Iris International.

¿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
    18899
  • Fecha de inicio del evento
    2015-07-28
  • 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
    Iris has confirmed the ichem velocity automated urine chemistry systems do not maintain the on-board strip stability claim of 10 days at 18-28 degrees c at 20-80% relative humidity as stated in the product labeling. the on-board strip stability is affected by temperature and humidity in the laboratory. if a laboratory operates outside of the defined parameters , test results may be affected as indicated below:, * false low or false negative results: ketone, blood, * false high or false positive results: bilirubin, urobilinogen, glucose, nitrite, * false high results: leukocytes, ascorbic acid, protein and ph are not affected.
  • Acción
    Instructions for use to be updated

Device

Iris iChem Velocity Automated Urine Chemistry System
  • Modelo / Serial
    Model: 800-3042, 800-3043, 800-3044, 800-3075, 800-3076, 800-3564, 800-7100, 800-7101, 800-7102, 800-7103, 800-7106, 800-7157, 800-7162, 800-7163, 800-7166, Affected: Manufactured between Apr-2011 and Jun-2015
  • Manufacturer
    Iris International

Manufacturer

Iris International