Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19326 |
| Brand Name: | Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction |
| Model: | Products Affected: CKMBL, Creatine Kinase-MB, GLDH3, Gen. 3, NH3 Unisys, Ammonia, NH3L, Ammonia |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| 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 type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/11/2015 |
