Beckman Coulter DxC 500i Analyzer Modules
Beckman Coulter recalls DxC 500i Analyzer Modules (software ≤1.5) over a Parameter Package import defect that can yield erroneous results.
If you use a Beckman Coulter DxC 500i Clinical Analyzer Module with software version 1.5 or lower, contact Beckman Coulter for a software update. Do not import a new Parameter Package until the update is applied, and review any results generated after a recent Parameter Package import for accuracy.
Why it was recalled
Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules running software version 1.5 or lower due to a software defect. When a new Parameter Package is imported, the import logic overwrites all predefined calculated test rules, including user-customized ones, silently reverting them to default expressions and potentially generating erroneous patient test results. New installations are not affected.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Recall # | UDI-DI |
|---|---|---|
| Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower | Z-2974-2026 | 14987666545058, 14987666545065 |
| Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower | Z-2973-2026 | 14987666545089, 14987666545072, 15099590742331 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Software Defect recalls
Other recent recalls from Beckman Coulter Inc.
Editorial summary by Recall Canary · summary updated 2026-08-18 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification