Events

Retiro De Equipo (Recall) de ichem VELOCITY Urine Chemistry Strips. 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
    Recall
  • ID del evento
    RC-2015-RN-01092-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-09
  • 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-01092-1
  • 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
    Beckman coulter has become aware of a manufacturing defect where multiple strips with multiple missing pads were found inside the strip vial for the affected lot number. if the affected strips are used, it may result in quality control failures and potential false negative results for any or all analytes and erroneous ph results if affected strips are used to assay patient samples.
  • Acción
    Beckman Coulter is advising users to discard affected lots. Any affected lots will be replaced by unaffected product. Beckman Coulter is advising users to consult with the Laboratory Director to determine if a retrospective review of results is clinically warranted. This action has been closed-out on 18/08/2016.

Device

ichem VELOCITY Urine Chemistry Strips. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    ichem VELOCITY Urine Chemistry Strips. An in vitro diagnostic medical device (IVD). Reference Number: 800-7204Lot Number: 7204089B ARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd