DxC 500 AU Clinical Chemistry Analyzer — Class II medical device recall Z-1672-2025
Ongoing recall by Beckman Coulter Inc., reported 2025-05-07, distributed nationwide. The reason for the recall is incorrect sample barcode identification and processing errors that result in the
| Recall number | Z-1672-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2025-03-17 |
| Classified | 2025-04-25 |
| Reported by FDA | 2025-05-07 |
| Distributed | Nationwide (US) |
| 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, SK, TN, ZA |
| UPC / GTIN / UDI-DI | 14987666545058, 14987666545065 |
| Serial numbers | 2023060005, 2023070009, 2023070010, 2023080012, 2023090015, 2023090016, 2023100019, 2023100020, 2023110022, 2023110023, 2024010024, 2024010025, 2024010027, 2024010028, 2024010029, 2024010030, 2024010031, 2024010032, 2024010033, 2024010034, 2024010035, 2024010036, 2024010037, 2024010038, 2024020041 and 111 more |
| Model numbers | C63519, C63520 |
Product
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 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
The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed 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-1672-2025. 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.