Events

Retiro De Equipo (Recall) de iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips

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
    Recall
  • ID del evento
    RC-2015-RN-00671-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-21
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00671-1
  • 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 ichemvelocity systems do not maintain the on-board strip stability claim of 10 days at 18-28 degrees celsius at 20-80% relative humidity (rh) as stated in the ichemvelocity product labelling. the on-board strip stability is affected by temperature and humidity in your laboratory. test results may be affected as indicated below:false low or false negative results: ketone, bloodfalse high or false positive results: bilirubin, urobilinogen, glucose, nitritefalse high results: leukocytesascorbic acid, protein and ph are not affected.
  • Acción
    Beckman Coulter is providing an updated stability guide and additional handling instructions to ensure the stability of the test strips. The manufacturer, Iris International, has determined that the Strip Provider Module is not maintaining the humidity levels associated with the original on-board strip stability claim and is urgently developing a corrective action. This action has been closed-out on 06/09/2016.

Device

iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips
  • Modelo / Serial
    iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry StripsStrip part numbers 800-7204 and 800-7204-001
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd