UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The… — Class II medical device recall Z-0147-2014
Terminated recall by Beckman Coulter Inc., reported 2013-11-13, distributed nationwide. Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and Uni
| Recall number | Z-0147-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2013-09-24 |
| Classified | 2013-11-04 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-04-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CH, CN, CZ, DE, ES, FR, GB, HK, HR, IE, IN, IT, JP, NL, NZ, PA, PL, PT, QA, SE, TH, TR, TW |
| Quantity | 1,025 units |
| Reason classes | packaging, device malfunction |
| Serial numbers | AM32020, AM32022, AM43032, AM48043, AM51048, AM51050, AM51052, AN05010, AN07019, AN07021, AN07022, AN10025, AN10027, AN10031, AN10033, AN20049, AN20057, AN20058, AN20060, AN30062, AN30064, AN30066, AN30069, AN30070, AN33075 and 475 more |
| Model numbers | 600, 629029, 800, B23858 |
Product
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, 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 tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only.
Reason for recall
Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company's internal investigation indicates that specific lots of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamb
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0147-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.