UniCel DxH 800 Coulter Cellular Analysis System — Class II medical device recall Z-1013-2017
Terminated recall by Beckman Coulter Inc., reported 2017-01-18, distributed nationwide. Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In r
| Recall number | Z-1013-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2016-12-19 |
| Classified | 2017-01-11 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CN, CZ, DE, EC, ES, FR, GB, HK, HR, IL, IN, IT, JO, JP, KR, KW, LB, MA, MX, MY, NZ, OM, PA, PH, PL, PT, QA, SA, SG, SK, TH, TR, TT, TW, UY, VN |
| Model numbers | 629029, B24465, B24802, B68304 |
Product
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
Reason for recall
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations.
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.