Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21072 |
| Brand Name: | Roche Cobas 4800 |
| Model: | |
| Affected: | cobas HBV Test for use on the cobas 4800 system (06979564190) |
| 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: | In extremely rare circumstances, the algorithm for the cobas® HIV-1 and HBV Tests for use on the cobas® 4800 system may inappropriately call an extraordinarily high viral load sample as negative (i.e., false negative result). This situation occurs when the positive PCR growth curve for the target has a Ct value below the Ct minimum for the test, resulting in the kinetic algorithm calling the curve negative instead of invalid. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/2/2017 |
