UNICEL DXH 800 COULTER CELLULAR ANALYSIS

by BECKMAN COULTER  · Based in United States → — Advanced Cellular Analysis for Clinical Laboratories
Hematology Laboratory Medicine
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Regulatory Status Disclosed

Overview

The Beckman Coulter UniCel DxH 800 Coulter Cellular Analysis System is a state-of-the-art, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. It is important to note that this is a laboratory instrument for cellular analysis and *not* an AI tool for a physician directory. The system combines advanced hardware technology with innovative computer algorithms, impedance technology, flow cell volume, conductivity, and five light scatter measurements to perform comprehensive analysis of blood and body fluids. It delivers accurate and reproducible results for complete blood count (CBC), white blood cell (WBC) differential, nucleated red blood cell (NRBC) enumeration, and reticulocyte analysis. The DxH 800 is engineered for high-throughput, efficiency, and reliability, supporting modern ‘Lean’ laboratory practices.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Use Cases

  • Routine complete blood count (CBC) and differential analysis in clinical laboratories
  • Screening patient populations for various medical conditions
  • Hematological research and experiments
  • Accurate detection and enumeration of nucleated red blood cells (NRBCs)
  • Monitoring of blood parameters in patients with extreme leukocytosis
  • Pediatric sample analysis due to low aspiration volume

What Physicians Need to Know

LIS/LIMS Integration
The UniCel DxH 800 connects with Laboratory Information Systems (LIS) for bidirectional data exchange, including patient sample information. It can also integrate with total laboratory automation systems, such as Inpeco's FlexLab, to create a seamless data pathway and reduce manual intervention.
Supported Assay Types
This hematology analyzer performs a comprehensive range of cellular analyses, including Complete Blood Count (CBC), 5-part and 6-part White Blood Cell (WBC) differentials, Nucleated Red Blood Cell (NRBC) enumeration, and reticulocyte analysis. It also supports body fluid analysis. Key parameters include WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, and full differential counts (NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#).
QC/QA Features
The system incorporates built-in quality control measures, automated maintenance routines, and a single aspiration pathway to simplify calibration and QC processes, ensuring consistent and reliable results. It utilizes specific reagents for quality control and calibration, and features for assessing calibration of WBC, RBC, HGB, and PLT parameters. A Remote Management System (RMS) provides proactive diagnostics and real-time troubleshooting to maximize instrument uptime.
Result Interpretation AI
The DxH 800 leverages advanced algorithm technology and innovative computer algorithms for data analysis. This includes defining 'signature positions' for NRBCs and identifying discrete WBC populations and common cellular interferences. Its Flow Cytometric Digital Morphology (FCDM) gathers significantly more data per cell, enhancing accuracy and potentially reducing manual review rates.
Critical Value Alerts
The instrument generates flags and messages for abnormal results, aiming to minimize manual interventions by highlighting specimens that require further review, such as a peripheral blood smear. While designed to alert, there was a past recall regarding erroneously elevated platelet results occurring without flags, emphasizing the importance of these alerts. Critical results, when flagged, are typically communicated immediately and documented in the LIS.
Instrument Interfaces
The DxH 800 supports flexible laboratory configurations, allowing connection of up to three analyzers and a DxH Slidemaker Stainer to form a Connected Hematology Workcell. It features automated sample handling with 'load 'n' go' capability via a Specimen Transport Module (STM) and includes a handheld barcode scanner for manual sample and reagent identification. It is also connectable to open-system total laboratory automation platforms.
Reference Range Intelligence
The system presents numerical results, histograms, plots, flags, and messages, comparing them against user-defined reference ranges. It is designed to effectively differentiate between patients with normal hematological parameters and those requiring additional studies.
Turnaround Time Impact
The DxH 800 is engineered to significantly enhance workflow efficiency, reduce manual review, and improve turnaround time (TAT). Features such as auto-rerun, reflex testing, true STAT interrupt, and intelligent workload distribution contribute to faster result delivery. Studies have demonstrated substantial reductions in TAT, with some reporting average full blood count results within 15 minutes.
Physician Tip

For clinicians, the UniCel DxH 800 provides high-definition cellular analysis, offering accurate and timely hematology results, including comprehensive CBC, differentials, NRBCs, and reticulocytes. Its advanced flagging system helps identify abnormal samples requiring further investigation, potentially reducing the need for manual smear reviews. Be aware of the system's capabilities for body fluid analysis. While highly automated, always correlate instrument results with clinical presentation and patient history, especially for flagged or borderline values. Note that a past recall highlighted the importance of vigilance regarding platelet counts, even without system flags.

The UniCel DxH 800 is designed for robust integration into laboratory workflows. It offers seamless connectivity with LIS/LIMS for efficient data management and can be configured into workcells with multiple analyzers and slidemaker/stainers. Its compatibility with total laboratory automation systems allows for scalable and future-proof laboratory solutions, optimizing throughput and minimizing manual handling from sample receipt to result reporting.

Details

Category Lab & Diagnostics
Pricing Contact vendor for pricing
  • Not publicly available; typically direct sales with custom quotes based on configuration and service agreements
DeploymentOn-premise laboratory instrument
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The UniCel DxH 800 COULTER Cellular Analysis System (K120771) received FDA 510(k) clearance on March 22, 2013, for in vitro diagnostic use. It is cleared as a quantitative multi-parameter, automated hematology analyzer for screening patient populations in clinical laboratories, performing complete blood count, leukocyte differential, nucleated red blood cell enumeration, and reticulocyte analysis.
Integrations
EHR Not specified
Specialties Hematology, Laboratory Medicine

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Press & Coverage

ProQuest
Performance Evaluation of the New UniCel DxH 800 Coulter Cellular Analysis System in a Large Hospital Setting
This study evaluated the UniCel DxH 800 Coulter Cellular Analysis System for its accuracy and clinical sensitivity in a large hospital setting, comparing it to the Coulter LH 750 Hematology Analyzer and manual differentials. The DxH 800 demonstrated accurate results for various parameters and improved efficiency in flagging abnormal results.
2012-08
PMC
Initial performance evaluation of the UniCelu00ae DxH 800 Coulteru00ae cellular analysis system
This article presents an initial performance evaluation of the Beckman Coulter UniCel DxH 800, highlighting its new electronic and mechanical design with advanced algorithm technology for CBC, WBC differential, NRBC, and reticulocyte analysis. The study found higher sensitivity and specificity for platelets and NRBCs compared to previous impedance analyzers.
unknown
healthcare-in-europe.com
A new instrument for mid-to-high volume labs
Beckman Coulter demonstrated the UniCel DxH 800 Coulter Cellular Analysis System at Euromedlab, targeting mid-to-high volume laboratories with its advanced technologies that produce significantly more data than traditional hematology analyzers. The instrument features a modular design and minimized moving parts for reliability and safety.
2009-05
American Journal of Clinical Pathology
Evaluation of the Beckman Coulter UniCel DxH 800
This study evaluated the Beckman Coulter DxH 800 against the Abbott Diagnostics Cell-Dyn Sapphire and Beckman Coulter LH 780, finding good correlation for CBC and differential parameters. The DxH 800 and Sapphire outperformed the LH 780 in nucleated RBC enumeration.
2011-06
accessdata.fda.gov
Class 2 Device Recall UniCel DxH 800 Coulter Cellular Analysis System
Beckman Coulter initiated a Class 2 recall for the UniCel DxH 800 and UniCel DxH 600 systems due to optical degradation potentially causing delayed reporting of results for nucleated red blood cells, automated white blood cell differential, and reticulocytes. An urgent product correction letter was sent to customers in November 2013.
2013-11
accessdata.fda.gov
April 16, 2020 Beckman Coulter Samy Puccio Staff Regulatory Affair Specialist
This FDA document from April 2020 discusses the UniCel DxH 800 Coulter Cellular Analysis System with an Early Sepsis Indicator Application, which quantitatively measures Monocyte Distribution Width (MDW) to aid in identifying adult patients with or at increased risk of sepsis. It also mentions a design change implemented as a corrective action for sporadically elevated platelet results.
2020-04
Annals of Laboratory Medicine
Performance Evaluation of Body Fluid Cellular Analysis Using the Beckman Coulter UniCel DxH 800, Sysmex XN-350, and UF-5000 Automated Cellular Analyzers
This study, published in March 2020, evaluated the performance of the Beckman Coulter UniCel DxH 800, Sysmex XN-350, and UF-5000 for body fluid cellular analysis. All three analyzers showed good agreement for total nucleated cell and red blood cell counts, with some differences in differential cell counting.
2020-03
unknown
UPDATED URGENT FIELD SAFETY NOTICE
This updated field safety notice from May 2019 addresses sporadic erroneously elevated platelet results on UniCel DxH 800, DxH 600, and DxH 900 systems, replacing a previous notice from August 2018. Beckman Coulter implemented an algorithm improvement through software upgrades or patches to resolve the issue.
2019-05

Videos

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Frequently Asked Questions

The UniCel DxH 800 employs advanced algorithm technology for comprehensive cellular analysis, including CBC and WBC differentials, aiming to enhance diagnostic confidence and streamline operations. It incorporates Flow Cytometric Digital Morphology (FCDM) to gather significantly more data per sample, which helps reduce manual review rates and corrects for common interferences using data fusion capabilities.
As an in vitro diagnostic device, the UniCel DxH 800 is subject to FDA regulations, including 21 CFR Parts 800-895, covering aspects like good manufacturing practice and labeling. While specific 'AI algorithm validation' in the modern sense isn't detailed, the system's algorithms undergo rigorous testing for accuracy, precision, and linearity to ensure reliable performance.
Key alternatives include the Sysmex XN-series, Abbott Alinity hq, and Siemens ADVIA 2120i, all offering high-throughput capabilities. The Abbott Alinity hq, for instance, leverages MAPSS technology with a machine-learning cell classifier, while Sysmex XN-series uses laser flow cytometry and complex algorithms for advanced flagging and automation.
New high-end hematology analyzers like the DxH 800 typically range from $50,000 to over $120,000 USD, though used units can be significantly less. Recurring costs are substantial and include reagents, consumables, calibration, and service contracts, which can surpass the initial equipment investment within a few years.
While the DxH 800 generally provides accurate results and compensates for common interferences, it may have limitations with extremely rare cell populations or highly atypical pathologies, often requiring manual microscopic review. There have been instances of recalls due to sporadic erroneously elevated platelet counts or high hemoglobin results in samples with elevated WBC counts, indicating specific algorithmic limitations.
The UniCel DxH 800 is designed to integrate with LIS and EHR systems through standard communication protocols, facilitating automated result transmission and order management. This integration minimizes manual data entry, reduces errors, and ensures efficient data flow for patient demographics and results.
Beckman Coulter provides ongoing support and software updates for the UniCel DxH 800, which include algorithm enhancements and bug fixes to maintain optimal performance. These updates are crucial for adapting to evolving diagnostic needs and incorporating technological advancements, ensuring the system remains current and reliable.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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