Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24849 |
| Brand Name: | TDM Vancomycin Gen.3 assay |
| Model: | |
| Affected: | TDM Vancomycin Gen.3 assay on cobas c platforms |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | The manufacturer is aware of a small number of reports about incorrectly low results for vancomycin in individual patient samples measured with the ONLINE TDM Vancomycin Gen.3 assay on cobas c platforms |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/7/2019 |
