Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21032 |
| Brand Name: | Roche Cobas ONLINE TDM Gentamicin |
| Model: | |
| Affected: | Cat. No. 04490843190 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | The manufacturer has become aware of the implementation of an Instrument Factor (IF) to mitigate the increased recovery of Gentamicin with the ONLINE TDM Gentamicin assay. Following further complaints and against initial data, the factor has been found to not correct the issue. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/1/2017 |
