Retiro De Equipo (Recall) de Dimension Tacrolimus (TACR) Flex Reagent Cartridge (An in vitro diagnostic medical device used with Dimension Clinical Chemistry Systems)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Ltd Diagnostics Division.

¿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 I
  • 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
    Siemens has confirmed that the tacr method may demonstrate reduced on-board stability which may result in imprecise and inaccurate qc and patient results. investigations have shown that results may become imprecise when tacr flexes are stored on-board the instrument for 2 days or more. this imprecision typically presents as one or more elevated tacr results following a period of instrument inactivity. subsequent results from the same well may exhibit depressed values. the discordant high results may be elevated by as much as 2 times the expected value and the discordant low results may be depressed by as much as fifty percent. longer periods of on-board storage (> 2 days) coupled with periods of instrument standby may increase the magnitude of elevated and depressed results.
  • Acción
    Siemens is asking customers to discard the remaining inventory of the affected stock. Also, Siemens is recommending discussing the issues with the laboratory director to determine if additional follow up is appropriate for TACR results reported in the laboratory. Beginning with TACR reagent cartridge lot BB4087, an “Alert Card” indicating that the on-board stability is limited to 8 hours, will be packaged with in the TACR cartons.


  • Modelo / Serial
    Dimension Tacrolimus (TACR) Flex Reagent Cartridge (An in vitro diagnostic medical device used with Dimension Clinical Chemistry Systems)Catalogue Number: DF107Lot Numbers: GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267, FB3267ARTG Number: 182779
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source