Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 34831 |
| Brand Name: | DxC 500i Clinical Analyzer |
| Model: | DxC 500 AU Module w/ISE, DxC 500i and DxC 500 AU Module, DxC 500i - SW 1.3.0 and 1.3.2 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Beckman Coulter NZ Ltd Suite 2, Level 4 30 St Benedicts Street Newton AUCKLAND |
| Contact Information: | 0800 446 109 |
| Manufacturer: | Beckman Coulter Inc |
| Issue: | The manufacturer has determined that the DxC 500i Clinical Analyzer may not run a requested calibration order for a two-part reagent and subsequently prevents any new calibration order from being placed. For two-part reagents, when reagent blank or calibration is ordered during sample processing and then any of the components (R1 and/or R2) depletes to zero tests, the analyzer will not be able to complete the calibration request, and the calibration order will remain pending. The analyzer will not allow additional calibration orders to be requested for any assays. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/3/2025 |
