Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24805 |
| Brand Name: | Elecsys Anti-CCP |
| Model: | Elecsys Anti-CCP e 411/601/602, Elecsys Anti-CCP e 801 |
| Affected: | |
| 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 received a number of reports of performance issues with certain lots of the Elecsys Anti-CCP assay when using plasma samples on the cobas e 601 and cobas e 602 systems. Sporadically cases have been reported on the cobas e 411 analyzer and cobas e 801 analytical unit. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 5/7/2019 |
