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
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 with LED HGB Photometer
- Model numbers
- UDI: 15099590192242, AV52143, AZ02628, AZ06676, AZ24836, BA07048, BA08667, BA17727 +4 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
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.
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
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Product Details
Model numbers: UDI: 15099590192242; AV52143; AZ02628; AZ06676; AZ24836; BA07048; BA08667; BA17727; BA31855; BB10648; BB49881; BC24713. Where sold: Worldwide distribution including US states listed in the recall. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Hazard is high risk due to potential erroneous lab results affecting patient diagnosis
- Recall date: 2025-08-13; Report date: 2025-09-24
- Product reference: REF:B23858
- Global distribution including US states listed in recall
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Safety Guide
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