UniCel DxH 600 Coulter Cellular Analysis System — Class II medical device recall Z-0434-2016
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-0434-2016 |
|---|---|
| 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 | B23858 |
Product
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
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.