Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14412 |
| Brand Name: | Roche Cobas 4800 system |
| Model: | |
| Affected: | Software version V1.1.x |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | In rare instances, channel shifted results have been generated with cobas® 4800 assays run on version 1.1.x of the cobas® 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: * channel 1 results report as channel 2, * channel 2 results report as channel 3, * channel 3 results report as channel 4, * channel 4 results report as channel 1. In the reported cases the results of the runs were invalid. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 5/4/2013 |
