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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Beckman Coulter
- Product type
- Hematology Analyzer
- Model numbers
- B24802, 629029, B63322, 15099590672423, 15099590381646, 15099590687922, AT38527, AU02008 +16 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 13, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
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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
- colors/sizes: Unknown
- Date of recall: 2025-08-13
- Country of origin: Unknown (manufacturer listed)
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