Events

Retiro De Equipo (Recall) de iChemVelocity Automated Urine Chemistry System using iChemVelocity Urine Chemistry Strips. An in vitro diagnostic 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
    Recall
  • ID del evento
    RC-2016-RN-00065-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-03
  • 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-2016-RN-00065-1
  • 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
    There have been complaints indicating that loose or missing analyte pads being found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the ichemvelocity system.If affected strips are used to assay patient samples, the issue has the potential to cause erroneous ph results and false negative results for the following tests:nitrite, glucose, blood, bilirubin, urobilinogen, protein, leukocyte esterase, ketones, and ascorbic acid.There is no impact to the measurement of colour, clarity and specific gravity.
  • Acción
    The sponsor is advising users to discard the vial and not use the strips from that vial when loading strips if loose or missing analyte pads are observed. Users should contact the sponsor for product replacement. A review of patients' results is at the discretion of the laboratory director. This action has been closed-out on 16/02/2017.

Device

iChemVelocity Automated Urine Chemistry System using iChemVelocity Urine Chemistry Strips. An in ...
  • Modelo / Serial
    iChemVelocity Automated Urine Chemistry System using iChemVelocity Urine Chemistry Strips. An in vitro diagnostic device (IVD)Reference Numbers: 800-7212; 800-7212-001; 800-7204; 800-7204-FJRAll Lot and Serial Numbers are affectedARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd