Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 34782 |
| Brand Name: | DxC 500i Clinical Analyzer |
| Model: | With ISE - DxC 500 AU Module w/ISE, DxC 500i, Access 2 Module, DxC 500i. Without ISE - DxC 500 AU Module, DxC 500i, Access 2 Module, DxC 500i |
| Affected: | SW 1.3.0 and 1.3.2 |
| 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 might assign a test result to an incorrect sample ID under the following workflow conditions. After loading a barcoded sample tube (Sample A) onto the DxC 500i Clinical Analyzer, all tests ordered for that barcoded sample tube are locked into the specific position of that barcoded tube on the analyzer (for example, the position on the DxLab Rack, Carousel Rack or position in the STAT table) until all tests are completed or cancelled for that sample tube. A problem might occur if, for any reason, all tests ordered for that barcoded sample tube (Sample A) are not completed or remain “in pending”, and the operator attempts to analyze a second sample tube (Sample B) in that same position on the rack or STAT table. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 5/3/2025 |
