Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-01025-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01025-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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...
  • Model / 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