Events

Retiro De Equipo (Recall) de Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction. 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-2015-RN-01025-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-20
  • 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-2015-RN-01025-1
  • 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
    Temozolomide may cause interference in assays using nad(h) or nadp(h). this has been confirmed in assays for gldh, ckmb and nh3, depending on the analyser used. it has been determined that the interference occurs at either very low analyte, or too high drug concentrations. these internal investigations were carried out with the therapeutic peak plasma concentration of 0.013 mg/ml temozolomide. higher drug concentrations were not systematically tested, because no literature reference for plasma concentrations > 0.013 mg/ml was found. the maximum bias for assays which showed interference at 0.013 mg/ml temozolomide is shown below:parameter % biasgldh + 62%ckmb - 31%nh3 + 36%this interference may results in falsely high or low results.
  • Acción
    Roche is advising laboratories of the potential drug interference. Test instructions for use are in the process of being updated. This action has been closed-out on 19/08/2016.

Device

Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction. An in vitro diagnostic medical d...
  • Modelo / Serial
    Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction. An in vitro diagnostic medical device (IVD).Products Affected: CKMBL, Creatine Kinase-MB, GLDH3, Gen. 3, NH3 Unisys, Ammonia, NH3L, AmmoniaMaterial Numbers: 04525299190, 11929992216, 11877984216, 20766682322, 05975581190Instruments Affected: COBAS INTEGRA, cobas c 501/502, MODULAR P, cobas c 701/702ARTG Number: 174906
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited