UniCel DxH 900 COULTER Cellular Analysis System — Class II medical device recall Z-2572-2025
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-2572-2025 |
|---|---|
| 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 | 15099590701574 |
| Serial numbers | BB33238, BB33239, BB42317, BC05150, BC08198, BC10226, BC16320, BC21392, BC23453, BC25457, BC25465, BC30527, BC32542, BC32545, BC42721, BC42726, BC49882, BD13219, BD41570, BD46639, BD46640, BD46642, BD46643, BD46646, BE01022 and 54 more |
| Model numbers | C11478 |
Product
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
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
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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.