Retiro De Equipo (Recall) de iChemVELOCITY Automated Urine Chemistry Systems. An in vitro diagnostic medical device (IVD).

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Beckman Coulter Australia Pty Ltd.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer, iris international, has determined that sample probe misalignment or bending on the ichemvelocity may lead to a remote possibility of false negative results due to inadequate strip dosing. inadequate dosing may lead to incorrect patient results which may not be detected by quality control, or to a delay in reporting results. incorrect patient results might be observed as an unexpected discrepancy between instrument results and the patient's clinical picture. the greatest impact could occur when proteinuria is not detected. a control failure could indicate inadequate dosing caused by probe bending/misalignment that occurred due to probe mishandling during maintenance or troubleshooting, or through use of an incorrect tube type or placement on the system.
  • Acción
    The manufacturer has designed a Pipette Mounting Block that will better secure the probe, avoiding misalignment and bending. A Beckman Coulter representative will contact customers to schedule a service visit for implementation. In the interim, the following actions are recommended: - Avoid bumping the probe during maintenance or troubleshooting. - Carefully follow instructions in your Operator’s Manual, PN 301-7146 or 300-4449, for utilising the Pipette Safety Parking Device, using the approved tube types, and removing tube caps before sample analysis to avoid probe-tube collisions. - Perform a patient cross check or run quality control after performing maintenance or troubleshooting in the probe area. If there are concerns with the results, contact Beckman Coulter. - Consult with the Laboratory Director to determine whether a retrospective review of results is clinically warranted.


  • Modelo / Serial
    iChemVELOCITY Automated Urine Chemistry Systems. An in vitro diagnostic medical device (IVD).Model Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061All Serial NumbersARTG Number: 181116
  • Manufacturer