Events

Retiro De Equipo (Recall) de Vancomycin Assay (performed on cobas C and Modular Analytics P-Module)

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

¿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
    Recall
  • ID del evento
    RC-2016-RN-00783-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-15
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00783-1
  • 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
    Previously, roche had received complaints about high recovery of the vancomycin assay in the context of external survey samples. to correct this, a lc-ms/ms reference method for the quantification of vancomycin was developed and released in 2014. as a result of this, updated instrument factors were required to correct possible high recovery and to align the various roche analysers. for the cobas integra system a slight adaptation of the reagent components is required instead of an updated instrument factor. since the cobas integra reagent is not yet adapted, results generated with this reagent are still higher by up to 20% in comparison to the cobas c modules or the modular analytics p-module. the method comparison in the ifu may lead to the assumption that both methods are comparable which may affect the interpretation of vancomycin test results.
  • Acción
    Incorrect method comparison will be deleted from the IFUs. Corrected IFU will be provided to all users. In the interim, Roche is advising users to disregard the incorrect method comparison in the Instructions for Use (IFU).

Device

Vancomycin Assay (performed on cobas C and Modular Analytics P-Module)
  • Modelo / Serial
    Vancomycin Assay (performed on cobas C and Modular Analytics P-Module)Online TDM Vancomycin Material Number: 04491050190Instrument affected: cobas c 501/502 moduleHitachi VancomycinMaterial Number: 04642481190 Instrument affected: MODULAR ANALYTICS P-MODULEARTG Number: 174910
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited