Events

Retiro De Equipo (Recall) de Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por manufacturer #1479.

¿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
    19326
  • Fecha de inicio del evento
    2015-11-11
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • 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 % bias, gldh + 62%, ckmb - 31%, nh3 + 36%, this interference may results in falsely high or low results.
  • Acción
    Instructions for use to be updated

Device

Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction
  • Modelo / Serial
    Model: Products Affected: CKMBL, Creatine Kinase-MB, GLDH3, Gen. 3, NH3 Unisys, Ammonia, NH3L, Ammonia, Affected: All lots
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479