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: 15099590729110, BD17734, BE12048, BE28105, BF14045, BF23096, BF46236, BG26135 +3 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 automate blood cell counting and measurement of hemoglobin. Labs use them to generate patient results for clinical decisions.
Why This Is Dangerous
A misreported hemoglobin value can influence diagnosis and treatment decisions. An erroneous high HGB result could lead to inappropriate management for patients with altered WBC counts.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Labs must halt use of affected devices. Potential workflow disruption and need for retesting patient samples.
Practical Guidance
How to identify if yours is affected
- Note if your device is UniCel DxH 690T COULTER with LED HGB Photometer REF C34520
- Check for the UDI 15099590729110 and listed model codes
- Review Beckman Coulter recall communications for your facility
- Verify if your device has an updated HGB photometer configuration or firmware
Where to find product info
FDA recall page Z-2573-2025 and Beckman Coulter recall notice on the manufacturer's site
What timeline to expect
4-8 weeks for refunds or replacements after verification
If the manufacturer is unresponsive
- Document all contacts and dates
- File a complaint with the FDA or your local regulatory body if the vendor is unresponsive
- Consult your hospital's compliance or legal team for guidance
How to prevent similar issues
- Verify model numbers and components before deployment in labs
- Regularly monitor supplier recall notices for hematology devices
- Ask vendors for recall status and remediation steps before purchasing
- Maintain an up-to-date inventory with UDIs and REF numbers
Documentation advice
Keep copies of recall notices, model numbers, UDI codes, email communications, and any submitted returns or replacement orders
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model numbers and configurations: UniCel DxH 690T COULTER Cellular Analysis System with LED HGB Photometer REF C34520. Distribution: Worldwide, including US nationwide distribution across states AL, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV. Countries: Algeria, Argentina, Australia, Bahrain, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Egypt, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Korea Republic of,
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- HGB photometer may overestimate hemoglobin
- Global distribution including US labs
- REF C34520 identified
- No injuries reported
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.