DxC 500 AU Clinical Chemistry Analyzer — Class II medical device recall Z-1233-2025
Ongoing recall by BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD., reported 2025-03-05, distributed in AL, CA, CO, GA, ID, IL, LA, MA…. Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct on
| Recall number | Z-1233-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD., Suzhou, N/A, China |
| Recall initiated | 2025-01-10 |
| Classified | 2025-02-25 |
| Reported by FDA | 2025-03-05 |
| Distributed | AL, CA, CO, GA, ID, IL, LA, MA, MI, MN, MS, NY, OK, OR, PA, PR, SC, TX, WA |
| Countries outside the US | AU, ES, GH, HR, KR, LB, PL, SK, ZA |
| Quantity | 56 |
| Reason classes | specification failure, software |
| UPC / GTIN / UDI-DI | 14987666545058, 14987666545065 |
| Serial numbers | 2023070009, 2023070010, 2023080012, 2023090015, 2023090016, 2023100019, 2023100020, 2023110022, 2023110023, 2024010024, 2024010025, 2024010029, 2024010031, 2024010033, 2024010035, 2024010036, 2024010037, 2024010038, 2024020041, 2024020042, 2024020043, 2024020045, 2024020046, 2024020047, 2024030049 and 29 more |
| Model numbers | C63519, C63520 |
Product
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Reason for recall
Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.
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-1233-2025. 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.