Events

Retiro De Equipo (Recall) de Reflotron Uric Acid (used with Reflotron Plus & Reflotron Sprint Single test 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 Roche Diagnostics Australia Pty Limited.

¿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-01239-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-17
  • 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-01239-1
  • 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 internal investigation detected deviations in uric acid results on the reflotron system which can be above the internal specification of 5%, if the haematocrit values in whole blood samples exceed 48%. this may lead to erroneously low uric acid results in such blood samples. roche diagnostics are updating the product insert to include the revised limit.
  • Acción
    Roche Diagnostics is advising users to note the haematocrit value limit has been reduced to a maximum of 48%, and advises users to take this into account when measuring patient samples from whole blood. Roche Diagnostics will be updating the Product Insert as a permanent correction.

Device

Reflotron Uric Acid (used with Reflotron Plus & Reflotron Sprint Single test chemistry systems) A...
  • Modelo / Serial
    Reflotron Uric Acid (used with Reflotron Plus & Reflotron Sprint Single test chemistry systems) An in vitro diagnostic medical device (IVD)Material Number: 10745103202All lot numbers affectedARTG number: 174909
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited