Beckman Coulter UniCel DxH 600 Hematology Analyzer with HGB Photometer Recalled in 2025
Beckman Coulter recalled the UniCel DxH 600 COULTER Hematology Analyzer configured with an LED HGB Photometer, distributed to laboratories worldwide. The device may produce erroneously high hemoglobin results when WBC counts are elevated. Labs and healthcare providers should stop using the device immediately and follow Beckman Coulter's recall instructions.
About This Product
This device is a hematology analyzer used in clinical laboratories to count blood cells and measure hemoglobin. Labs rely on accurate HGB readings for diagnostic decisions.
Why This Is Dangerous
The LED HGB Photometer configuration can produce spuriously high hemoglobin readings on samples with elevated WBC counts, potentially impacting patient care.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Labs may need to halt testing with affected devices, validate patient results from other instruments, and manage workflow disruption and potential financial impact.
Practical Guidance
How to identify if yours is affected
- Check device model against recall list and REF:B23858
- Inspect for LED HGB Photometer configuration on UniCel DxH 600
- Review inventory and isolate affected units from use
Where to find product info
Consult the recall notice and Beckman Coulter recall page for identifiers and instructions
What timeline to expect
Remedy processing typically occurs within 4-12 weeks, depending on inventory and service arrangements
If the manufacturer is unresponsive
- Document all communications with Beckman Coulter
- Escalate to hospital risk management and regulatory bodies if the company is slow to respond
- Consider filing safety reports with FDA MedWatch if patient safety is affected
How to prevent similar issues
- Before purchasing or deploying hematology analyzers, verify recall status and configuration options
- Maintain an up-to-date asset register with UDI and reference numbers
- Work with vendors to ensure devices meet validated configurations and safety alerts
- Regularly review FDA recall databases for updates
Documentation advice
Keep a copy of the recall notice, record serial numbers and UDI, log all correspondence with Beckman Coulter, and document patient impact assessments