UniCel DxH 800 Coulter Cellular Analysis System — Class II medical device recall Z-1828-2014
Terminated recall by Beckman Coulter Inc., reported 2014-07-02, distributed in PR. Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical
| Recall number | Z-1828-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2013-11-08 |
| Classified | 2014-06-20 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2014-12-25 |
| Distributed | PR |
| Countries outside the US | AE, AU, BE, CA, CH, CN, CO, CZ, DE, ES, FR, GB, GR, HK, HR, HU, IE, IN, IT, JP, KR, KW, MX, MY, NL, NO, NZ, OM, PA, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TR, TT, TW, VN |
| Reason classes | specification failure |
| Model numbers | 629029, B24465, B24802 |
Product
UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Reason for recall
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.
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.