Events

Retiro De Equipo (Recall) de iQ200 Series Urine Microscopy Analysers

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-2018-RN-00225-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-03-22
  • 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-2018-RN-00225-1
  • 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 determined that there is a potential for under-reporting casts. this can occur if per high-power field (/hpf) units of measurement for casts are selected in the iq200 software, but the abnormal threshold and/or grading format is set up based on reporting “per low-power field (/lpf)” or “per microliter (/µl). this may occur during initial method validation or if settings are altered after the initial validation.
  • Acción
    Beckman Coulter is advising they will contact users to schedule a site visit to verify the reporting units of measurement for casts for their laboratory within 90 days of this recall initiation.

Device

iQ200 Series Urine Microscopy Analysers

Manufacturer

Beckman Coulter Australia Pty Ltd