Retiro De Equipo (Recall) de Access Free T3 Reagent Kit (used in the diagnosis and monitoring of patients with thyroid disorders). 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 through customer feedback and internal testing that the access free t3 reagent lots demonstrate an upward shift in patient results. the preliminary results indicate this upward shift may be related to a june 2015 formulation design change that was introduced to improve the access free t3 open reagent pack stability. the upward shift in patient test results, therefore, is expected to be maintained for all future lots. patient sample results will shift upward by approximately 10-14% across the reference interval when compared to the results generated with reagent lots manufactured prior to the june 2015 design change. due to matrix differences, qc values may not demonstrate a shift.
  • Acción
    Beckman Coulter is advising users to discontinue use of the affected product and either verify the current Free T3 references interval(s) are appropriate or adjust or establish new reference intervals(s). Use of the affected lots can be resumed once the reference intervals have been evaluated. A review of previously generated results and clinical notification is at the discretion of the Laboratory Director. This acrtion has been closed out on 16 June 2017.


  • Modelo / Serial
    Access Free T3 Reagent Kit (used in the diagnosis and monitoring of patients with thyroid disorders). An in vitro diagnostic medical device (IVD)Reference Number: A132422Multiple lot numbers affectedARTG Number: 213976
  • Manufacturer