UniCel DxH 600 Coulter Cellular Analysis System — Class II medical device recall Z-0433-2016
Terminated recall by Beckman Coulter Inc., reported 2015-12-23, distributed nationwide. Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software vers
| Recall number | Z-0433-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2015-12-01 |
| Classified | 2015-12-16 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2017-01-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CN, CO, CZ, DE, EC, ES, FR, GB, GR, HK, HR, HU, IE, IL, IN, IT, JO, JP, KR, KW, LB, LT, MA, MX, MY, NL, NO, NZ, OM, PA, PH, PL, PT, RO, SA, SG, SI, SK, TH, TR, TT, TW, UY, VN |
| Reason classes | software |
| Model numbers | 775222 |
Product
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only.
Reason for recall
Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager.
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.