DxC 500 AU Module w/ISE — Class II medical device recall Z-0032-2026
Ongoing recall by Beckman Coulter Inc., reported 2025-10-08. On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immuno
| Recall number | Z-0032-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2025-08-04 |
| Classified | 2025-10-02 |
| Reported by FDA | 2025-10-08 |
| Countries outside the US | AE, BR, CA, CH, CL, CW, CZ, DE, DO, DZ, ES, FR, GB, HU, ID, IE, IN, IT, KR, LB, MA, MY, NP, NZ, OM, PH, PL, QA, SA, SV, TH, TR |
| Quantity | 116 |
| UPC / GTIN / UDI-DI | 14987666545072, 14987666545089 |
| Model numbers | 500AU, 500I, C6352, C63522 |
Product
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
Reason for recall
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.
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-0032-2026. 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.