Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37451 |
| Brand Name: | DxC 500i Clinical Analyzer |
| Model: | With ISE DxC 500 AU Module w/ISE, DxC 500i and Without ISE DxC 500 AU Module, DxC 500i |
| Affected: | Software - 1.3.5 or earlier |
| 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 identified a software issue affecting DxC 500i Clinical Analyzer when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyser to revert the test units to the system default setting without notifying the user. The system does not provide a warning or notification to alert the user that the configured units have reverted to the default units. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/9/2026 |
