Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21663 |
| Brand Name: | XN-L series analyser |
| Model: | |
| Affected: | XN-L series instruments: version 00-13 and above |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Sysmex Corporation |
| Issue: | It has been reported that the WBC could become falsely low when the following steps are performed: Manual mode is selected Whole blood mode (WB), PreDilute mode (PD) or body fluid mode (BF) is changed to low WBC mode (LW). The measurement information is input in the manual order dialogue and the menu is closed by selecting 'Ok'. No measurement is performed in LW mode, and the mode is then changed to use another measurement mode (ie either WB, PD, BF). With the next measurement, the WBC result becomes diluted and gives a result half of the correct WBC value. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 5/7/2017 |
