Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20984 |
| Brand Name: | Roche Diagnostics Cobas c501/502 XN-9000 |
| Model: | |
| Affected: | XN-9000 complete with XN-10/20 on Version 20 Build 8 |
| 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 been notified of a software bug identified on the XN-9000 line products in which patient information was replaced by that of another patient resulting in incorrect patient demographics being assigned to the patient sample and the results reported. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 23/12/2016 |
