Events

Retiro De Equipo (Recall) de CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro. 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-2013-RN-00415-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-09
  • 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-2013-RN-00415-1
  • 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 has discovered that in rare cases (<0.00015%) an “error 6” may also be displayed by individuals who are under treatment with warfarin in combination with antibiotics and/or chemotherapeutics. in such patients inr values could be extremely high (>10 inr). the coaguchek displays the various codes when it suspects there could be a problem with the actual measurement of your inr. "error 6” when shown in the display represents alerts to a number of issues with the testing.
  • Acción
    In the event of an "error 6" end users are advised to repeat the test and if the error continues contact their physician immediately. The package insert for the CoaguChek XS PT strips will be updated to contain this information. For more information, please see http://www.tga.gov.au/safety/alerts-device-coaguchek-inr-monitors-130516.htm .

Device

CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro. An in vitro diagnostic medical device (IVD)Material numbers: 04796179001, 04811500001, 04963733001, 06505597001, 04800842190, 05864640001, 06505589001, 06644511001, 05530199190
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited