Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27104 |
| Brand Name: | cobas ® infinity |
| Model: | |
| Affected: | cobas infinity central lab |
| 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 result status SI_WSI (Serum Index pending) flag is removed when an alphanumeric result (i.g. ABC123) is received in cobas ® infinity potentially leading to an undetected poor quality sample. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 23/12/2020 |
