Quick Facts at a Glance
- Recall Date
- August 13, 2025
- Hazard Level
- HIGH
- Brand
- Beckman Coulter
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478, UDI: 15099590701574/ BB33238, BB33239, BB42317, BC05150, BC08198, BC10226, BC16320 +13 more
- Sold at
- Unknown
- 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
The UniCel DxH 900 is a high-throughput hematology analyzer used in clinical labs to measure blood components. It is valued for speed and accuracy in identifying hematologic parameters.
Why This Is Dangerous
The HGB photometer configuration can inflate hemoglobin readings in samples with high WBC counts, potentially impacting clinical decisions.
Industry Context
This recall is part of ongoing scrutiny of hematology analyzers and photometer configurations in clinical diagnostics.
Real-World Impact
Clinicians may need to re-test or confirm results and may face workflow disruptions during remediation.
Practical Guidance
How to identify if yours is affected
- Review device model: UniCel DxH 900 COULTER with Led HGB Photometer REF: C11478
- Check UDI: 15099590701574 or serial numbers like BB33238, BB33239, BB42317 etc.
- Confirm configuration is HGB photometer-equipped
Where to find product info
Recall notice, FDA enforcement page Z-2572-2025, Beckman Coulter support
What timeline to expect
Remediation timelines not specified; expect weeks to months for replacement/repair
If the manufacturer is unresponsive
- Escalate to Beckman Coulter customer support
- File a report with FDA if manufacturer is nonresponsive
How to prevent similar issues
- Verify device configurations before purchase
- Ask for documentation on photometer configuration in future purchases
- Maintain a recall contact plan with your facility's procurement and biomedical teams
Documentation advice
Document model numbers, serials, dates, and correspondence; retain all recall notices and vendor communications
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Product Details
Brand: Beckman Coulter. Product: UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer. Reference: C11478. Distribution: Worldwide, including US states listed in notice and numerous countries. Date of recall: 2025-08-13. Status: ACTIVE.
Reported Incidents
No specific incident numbers are provided in the notice. The recall status is active with HIGH hazard level.
Key Facts
- Device: UniCel DxH 900 with HGB photometer
- Worldwide distribution including US and numerous countries
- Hazard: erroneous high HGB due to WBC interference
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Safety Guide
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