Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21713 |
| Brand Name: | cobas 8000 core unit |
| Model: | |
| Affected: | Software versions 05-02, 06-02 and 06-03 |
| Software version: | |
| Recalling Organisation: | Roche Consumer Health, Division of Roche Products (NZ) Limited 8 Henderson Place Te Papapa AUCKLAND |
| Contact Information: | |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | A software issue has been identified, which in rare cases resets the system configuration of the control unit software to "default". The issue may occur during initialisation of the system setting information database. If a reading failure occurs any of the following symptoms can be identified: 1. The date and time in the Status Line on screen is not displayed. 2. The information about the "Analytical Unit" (AU) is not displayed in the Data Review screen - but is displayed in Test Review. 3. The year/month/date/time of the Printout Preview on the History screen is not displayed. 4. CU settings under Utility-System are set to "default". |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 25/7/2017 |
