Events

Retiro De Equipo (Recall) de Reflotron Hb Test Strips, an in vitro diagnostic medical device (IVD) intended for the quantitative measurement of haemoglobin in venous blood samples

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-2013-RN-00112-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-06
  • 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-2013-RN-00112-1
  • 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
    Roche diagnostics has confirmed that there is an increase in imprecision leading to higher results of the haemoglobin (hb) measurement when using capillary samples on the reflotron systems. testing with venous samples is not affected by this issue.
  • Acción
    The use of capillary blood samples with Reflotron is no longer recommended. The package insert will be amended to reflect this change. It is recommended that the recall letter is retained with the Reflotron Hb test strips until the package insert has been updated.

Device

Reflotron Hb Test Strips, an in vitro diagnostic medical device (IVD) intended for the quantitati...
  • Modelo / Serial
    Reflotron Hb Test Strips, an in vitro diagnostic medical device (IVD) intended for the quantitative measurement of haemoglobin in venous blood samplesMaterial Number: 10744964202All lot numbers
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited