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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01025-1
Product Name/Description	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, Ammonia Material Numbers: 04525299190, 11929992216, 11877984216, 20766682322, 05975581190 Instruments Affected: COBAS INTEGRA, cobas c 501/502, MODULAR P, cobas c 701/702 ARTG Number: 174906
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	20/10/2015
Responsible Entity	Roche Diagnostics Australia Pty Limited
Reason/Issue	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.
Recall Action	Recall for Product Correction
Recall Action Instructions	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.
Contact Information	02 9860 2357 - Roche Diagnostics