Retiro De Equipo (Recall) de ADVIA Chemistry Triglyceride Concentrated (TRIG_c) Reagent. 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 Siemens Healthcare 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
    Siemens healthcare diagnostics has confirmed the advia chemistry triglyceride concentrated reagent (trig_c) does not meet instructions for use (ifu) linearity claim at the upper limit of the assay range as it approaches the end of its shelf life. internal testing indicates that a patient bias (-7% to -12%) may be seen at concentration levels from 6.22 to 6.78 mmol/l. linearity is reduced by approximately 50% at triglyceride concentrations approaching the upper end of the extended range of 12.43 mmol/l.Quality control (qc) material may not detect this issue depending on the triglyceride concentrations in the qc material.Siemens internal testing has confirmed all other in date lots are currently meeting linearity ifu claims. however, as a precaution, until root cause is determined, a short term mitigation of reducing the expiration date to 6 months for all lots of advia chemistry systems triglyceride concentrated has been implemented.
  • Acción
    Siemens is advising users to discontinue use and discard any remaining stock of lots 365096 and 379597. Discontinue use and discard remaining lots once they reach the revised shelf life. Customers will need to manually monitor the revised expiration dates for the impacted lots. A review of previously generated results is at the discretion on the Laboratory Director.


  • Modelo / Serial
    ADVIA Chemistry Triglyceride Concentrated (TRIG_c) Reagent. An in vitro diagnostic medical device (IVD)Catalogue Number: 10697575Lot Numbers: 365096, 379597, 379919, 379930, 379942, 379946, 376894ARTG Number:176642
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source