DxC 500 AU Clinical Chemistry Analyzer — Class II medical device recall Z-1784-2025
Ongoing recall by Beckman Coulter Inc., reported 2025-05-21, distributed in AL, CA, GA, ID, IN, LA, MA, MI…. Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the
| Recall number | Z-1784-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2025-03-20 |
| Classified | 2025-05-15 |
| Reported by FDA | 2025-05-21 |
| Distributed | AL, CA, GA, ID, IN, LA, MA, MI, MN, MT, NC, NV, PA, PR, TN, TX, WI |
| Countries outside the US | AU, BE, CA, CH, CL, DE, EG, ES, FR, GH, HR, IN, IT, KR, LB, MY, NL, OM, PH, PL, PY, QA, SA, TN, ZA |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 14987666545058, 14987666545065 |
| Serial numbers | 500AU |
| Model numbers | C63519, C63520 |
Product
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
Reason for recall
Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a 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. No further calibration orders can be processed for any assays, and the instrument refuses to accept further sample processing order after the existing calibration curves are expired. Although in-process tests will be completed, this error can cause a delay in reporting subsequent test results. No further calibration orders can be processed for any assays which may cause a delay in reporting test results.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.