Unicel DxH 800 Coulter Cellular Analysis System — Class II medical device recall Z-0021-2013
Terminated recall by Beckman Coulter Inc., reported 2012-10-17, distributed nationwide. Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differentia
| Recall number | Z-0021-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2012-04-03 |
| Classified | 2012-10-09 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2013-06-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CO, CZ, DE, ES, FR, GB, GR, HK, HR, HU, IL, IN, IT, JP, KR, KW, MX, MY, NL, NO, OM, PA, PH, QA, RO, SA, SE, SG, SI, SK, TH, TR, TW |
| Reason classes | foreign material, chemical contamination |
| Model numbers | 629029 |
Product
Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Reason for recall
Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps, and result in biohazard or chemical exposure and/or the potential for generating incorrect results.
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.