Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23382 |
| Brand Name: | Sysmex XN-10/20 |
| Model: | Instrument: XN-10 / 20 instrument |
| Affected: | All instruments on SW Ver 22.04. |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Sysmex Corporation |
| Issue: | The manufacturer has cidentified an issue regarding incorrect discrimination in the XN-series differential (WDF) channel between the Eosinophil and Neutrophil cell populations. This may result in discrepancies between the automated eosinophil count and the manual differential eosinophil count. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 25/7/2018 |
