Retiro De Equipo (Recall) de VITROS Chemistry Products VANC 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 Ortho-Clinical Diagnostics 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
    Ortho clinical diagnostics (ortho) has identified the potential for biased results generated using vitros vanc reagent. this can occur after the reagent packs are loaded onto the analyser and stored within the on-analyser stability date. some customers observed a positive drift of >2 standard deviation (sd) in quality control results when using vitros tdm performance verifiers (levels i, ii & iii). ortho's testing confirmed a positive drift in patient and quality control results within a reagent pack in as few as approximately 7 hours. for the affected lots, results may begin to show a drift as soon as packs are loaded onto the system. the magnitude of positive drift for the affected reagent packs is approximately 8-15% across the vanc reportable measuring range of 5.00–50.00 ìg/ml (3.35–33.50 (ìmol/l).
  • Acción
    Users are advised to immediately discontinue using and discard all remaining inventory of VITROS VANC Reagent Packs for the affected lots listed above. Discuss any concerns users may have regarding previously reported results with their Laboratory Medical Director to determine the appropriate course of action. If users do not have an alternate lot in their inventory and have an urgent need to continue testing Vancomycin, they are advised to use the current lot provided that they perform quality control testing with every sample batch (i.e., 1 or more patient samples). Ortho recommends the following: - Run QC fluids prior to and following each sample batch. (Use a minimum of one control fluid at the beginning and end of each sample batch) - Ensure QC results are within acceptable limits prior to releasing sample results until replacement product arrives.


  • Modelo / Serial
    VITROS Chemistry Products VANC Reagent. An in vitro diagnostic medical device (IVD).Product Code: 6801709Lot Numbers: 31-5407 (Exp. 23 May 2017), 31-5474 (Exp. 4 July 2017) , 31-5506 (Exp. 4 July 2017)ARTG Number: 245278
  • Manufacturer