Events

Rappel de Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction. An in vitro diagnostic medical device (IVD).

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Roche Diagnostics Australia Pty Limited.

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
    RC-2015-RN-01025-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-20
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01025-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • 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 % biasgldh + 62%ckmb - 31%nh3 + 36%this interference may results in falsely high or low results.
  • Action
    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...
  • Modèle / numéro de série
    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