Is this recall related to all UniCel DxH 800 devices?

The recall covers hematology analyzers configured with the Led HGB photometer and listed reference numbers. Confirm your configuration and model against the recall documentation.

What should I do if I own an affected device?

Stop using the device immediately. Follow the manufacturer instructions and contact Beckman Coulter or your healthcare provider for further guidance.

Will there be refunds or replacements?

Remedies are determined by the manufacturer; check recall notices for refund or replacement options.

How can I verify if my device is affected?

Compare your device model and configuration to the listed references in the recall notice and FDA enforcement report.

Where can I get more information?

FDA enforcement report Z-2574-2025 and Beckman Coulter recall notices provide details.

What about patient safety until resolution?

Follow clinical guidance and avoid relying on potentially inaccurate HGB results from the device.

Who is the manufacturer?

Beckman Coulter, a unit of Danaher Corporation, is the manufacturer.

Is the issue limited to the United States?

The recall states worldwide distribution, including many countries.

HGB results may be erroneously high on samples with elevated WBC counts.

What is the timeframe for recall resolution?

Timeline not specified in the provided data; refer to official recall updates.

How is the recall communicated?

Notification method listed as Email through the recall process.

HIGHAugust 13, 2025

Beckman Coulter UniCel DxH 800 Hematology Analyzers Recalled for High Hemoglobin Readings in High-WB

Beckman Coulter recalled the UniCel DxH 800 COULTER Cellular Analysis System configured with the Led HGB photometer. The recall affects models B24802, 629029, and B63322 and related configurations. A design-linked issue can yield erroneously high hemoglobin results when samples have elevated white blood cell counts. Stop using the device and follow the manufacturer’s recall instructions. Contact a

Quick Facts at a Glance

Recall Date: August 13, 2025
Hazard Level: HIGH
Brand: Beckman Coulter
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL, PREGNANT, INFANTS

Hazard Information

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter Inc. or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

Hematology analyzers are used in clinical labs to count and characterize blood cells and measure components such as hemoglobin. The specified configuration uses an HGB photometer to measure hemoglobin levels.

Why This Is Dangerous

The HGB photometer configuration can produce inflated hemoglobin readings when WBC counts are elevated, potentially affecting diagnosis and treatment decisions.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

Potential for misdiagnosis or inappropriate treatment due to inaccurate HGB values. Medical facilities may need to re-run tests on affected samples.

Practical Guidance

How to identify if yours is affected

Compare device configuration to B24802, 629029, B63322 and related references.
Verify serials and configuration against the FDA enforcement report Z-2574-2025.
Check for presence of Led HGB photometer configuration.

Where to find product info

FDA enforcement report and Beckman Coulter recall notices linked to the recall number Z-2574-2025.

What timeline to expect

Repair or replacement timelines are determined by Beckman Coulter and healthcare providers; no fixed window provided.

If the manufacturer is unresponsive

Escalate to hospital biosafety officer or clinical engineering department
File a formal inquiry with Beckman Coulter support and the FDA recall contact

How to prevent similar issues

Ensure device configurations are documented
Coordinate with clinical engineering for validation
Maintain up-to-date recall notifications for all analyzers in use

Documentation advice

Keep recall notices, device configuration records, and correspondence with Beckman Coulter for compliance and safety audits

Product Details

Brand: Beckman Coulter. Product: UniCel DxH 800 COULTER Cellular Analysis System with Led HGB Photometer. Ref:s: B24802, 629029, B63322. Scope: Worldwide distribution including extensive U.S. states and dozens of countries. Status: Active recall as of 2025-08-13.

Reported Incidents

No specific incident counts are provided in the source material. The recall notice labels hazard level as HIGH.

Key Facts

Brand: Beckman Coulter
Model numbers: B24802, 629029, B63322
Other models/refs listed: 15099590672423, 15099590381646, 15099590687922, AT38527, AU02008, AU10078,
colors/sizes: Unknown
Date of recall: 2025-08-13
Country of origin: Unknown (manufacturer listed)

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERALPREGNANTINFANTSCHILDRENPETS

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeHematology Analyzer

Product Details

Brand

Beckman Coulter

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