Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25629 |
| Brand Name: | Elecsys® CA 19-9 |
| Model: | |
| Affected: | Non-reproducible elevated results with reagent lots 416245, 464449,483123, 504743, 525510, 568976,598135, 598140 and 599263 |
| 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 complaints concerning non-reproducible elevated results (high flyers)for lots 416245, 464449, 483123, 504743, 525510 and 568976, Elecsys® CA 19-9 on cobas e801 and cobas e402. The issue is reagent lot specific and not related to the cobas e801 or 402 instrument.The issue can lead to non-reproducible elevated CA 19-9 results and therefore affect clinical interpretation (either result of multiple results is discrepant-high compared to other results of the same sample). |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/11/2022 |
