Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26932 |
| Brand Name: | cobas z480 |
| Model: | |
| Affected: | a dirty lens. |
| 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 has advised that the availability of the Maintenance Checker software for the cobas z 480 analyzer, which must be installed on all cobas z 480 analyzers running any cobas® 4800 assay in the IVD workflow. This service tool aids in identifying conditions that could contribute to the generation of false positive results due dirty optical lenses and spatial cross-talk. Stringent criteria have been established to identify a dirty lens before false positive results are generated. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/2/2022 |
