Events

Rappel de Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par manufacturer #1479.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    19326
  • Date de mise en oeuvre de l'événement
    2015-11-11
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Cause
    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.
  • Action
    Instructions for use to be updated

Device

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

Manufacturer

manufacturer #1479