Coulter DxH Cleaner 10L — Class II medical device recall Z-1831-2014
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-1831-2014 |
|---|---|
| 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 |
| Lot numbers | 3040210, 3040330, 3043090, 3043100, 3057970, 3057980, 3058130, 3071440, 3071450 |
| Model numbers | 628023 |
Product
Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
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.