Events

Retiro De Equipo (Recall) de ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. 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 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-00712-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-26
  • 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-00712-1
  • 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
    Investigations by roche have confirmed an increase in native patient sample result recovery of approximately 15 – 20% when using certain lot combinations of online tdm gentamicin with preciset tdm i calibrator. a combination with tdm control set lot 125783 does not show this effect. this may result in sub therapeutic serum levels of gentamicin leading to a delay in treatment and potentially leading to the spread of infections.
  • Acción
    Roche is advising users to immediately stop using ONLINE TDM Gentamicin reagent until further notice. Stock does not need to be discarded at this time. Users may continue to use the Preciset TDM I Calibrator for all other TDM assays on cobas c modules and MODULAR ANALYTICS (except for GENT2) and for all TDM (including GENTM) on COBAS INTEGRA systems. This action has been closed-out on 15/02/2017.

Device

ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. An in vitro diagnostic medical device ...
  • Modelo / Serial
    ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. An in vitro diagnostic medical device (IVD)ONLINE TDM Gentamicin, 100 testsMaterial Number: 04490843190Lot Numbers: 119166, 611780, 617623ONLINE TDM Gentamicin, 100 testsMaterial Number: 05841291190Lot Numbers: 119167, 611783, 617624Preciset TDM I CalibratorMaterial Number: 03375790190Lot Numbers: 615118, 619681, 126387, 140735ARTG Number: 174910
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited