Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26973 |
| Brand Name: | cobas |
| Model: | cobas® 8000 Core Unit, cobas pro sample supply unit, cobas c 513 analyse, cobas® 8000 modular analyser series. |
| Affected: | |
| 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 received a customer complaint for the cobas® 8000 modular analyser series where due to a software limitation; the system stopped reading barcoded samples with loss of Utility settings. Two similar complaints were received for cobas pro integrated solutions. While no impact on patient results occurred, internal investigations revealed that for some settings under specific conditions, the occurrence of this situation may remain undetected and leads to deactivation of clotting and foam data flags. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/3/2023 |
