Retiro De Equipo (Recall) de Immulite 2000 / Immulite 2000 XPi Sex Hormone Binding Globulin (SHBG). 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 that the immulite 2000/immulite 2000 xpi sex hormone binding globulin (shbg) adjustor lots 124 and 125 packed with specific reagent lots do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8°c, as published in the instructions for use. reconstituted adjustors stored at 2-8°c after a two week (14 days) period may show a bias in patient samples and may result in quality control falling outside of established ranges. the reagent lots affected can exhibit an average bias of 14.5% at day 21 to 16.5% at day 28 (for shbg concentrations of 5 nmol/l to 170 nmol/l) during the open vial adjustor stability period of 30 days. the bias observed was not concentration dependent. this issue does not impact the immulite/immulite1000 platforms.
  • Acción
    Siemens is advising that reconstituted adjustor lots 124 and 125 are to be stored at 2-8°C or -20°C for up to 14 days, after which they must be discarded. Based on the recommended calibration interval, this allows two calibration events at day 1 and 14 after opening the SHBG reagent kit. Replacement product can be requested from Siemens if adjustors available in the laboratory are not sufficient to utilise the full reagent kit. The customer letter should be reviewed by the laboratory Medical Director and review of previously generated results is at the discretion of the laboratory.


  • Modelo / Serial
    Immulite 2000 / Immulite 2000 XPi Sex Hormone Binding Globulin (SHBG). An in vitro diagnostic medical device (IVD).Catalogue Number: L2KSH2Siemens Material Number: 10381198Lot Numbers: 357 (Exp. 30 Jan 2017), 358 (Exp. 31 Mar 2017), 360 (Exp. 30 Apr 2017), 361 (Exp. 31 May 2017), 363 (Exp. 30 Jun 2017)ARTG number: 179720
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source