UniCel DxH 800 COULTER Cellular Analysis System — Class II medical device recall Z-2574-2025
Ongoing recall by Beckman Coulter Inc., reported 2025-09-24, distributed nationwide. Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results o
| Recall number | Z-2574-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2025-08-13 |
| Classified | 2025-09-17 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BH, BR, CA, CH, CL, CN, CZ, DE, DZ, EG, ES, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IT, JO, JP, KE, KR, KW, LT, MX, NL, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RS, SA, SG, SI, SK, TH, TT, TW, UY, VN |
| UPC / GTIN / UDI-DI | 15099590381646, 15099590672423, 15099590687922 |
| Serial numbers | AT38527, AU02008, AU10078, AV28630, AW13187, AW29123, AW43276, AY06074, AY06092, AY41556, AY43605, AZ02030, AZ03041, AZ18245, AZ22329, AZ25376, AZ39513, AZ46681, BA03048, BA03050, BA03055, BA03060, BA07061, BA07062, BA13227 and 11 more |
| Model numbers | 629029, B24802, B63322 |
Product
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Reason for recall
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
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-2574-2025. 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.