DxC 500 AU Clinical Chemistry Analyzer — Class II medical device recall Z-1517-2025
Ongoing recall by Beckman Coulter Inc., reported 2025-04-09, distributed nationwide. Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect
| Recall number | Z-1517-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2025-02-26 |
| Classified | 2025-04-03 |
| Reported by FDA | 2025-04-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, DE, EG, ES, FR, GH, HR, IN, IT, KR, LB, MY, NL, OM, PH, PL, PY, QA, SA, SK, ZA |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 14987666545058, 14987666545065 |
| Serial numbers | 2023060005, 2023070009, 2023070010, 2023080011, 2023080012, 2023090015, 2023090016, 2023100018, 2023100019, 2023100020, 2023110022, 2023110023, 2024010024, 2024010025, 2024010026, 2024010027, 2024010028, 2024010029, 2024010030, 2024010031, 2024010032, 2024010033, 2024010034, 2024010035, 2024010036 and 118 more |
| 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 has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1517-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.