HIGH

Beckman Coulter UniCel DxH 690T Hematology Analyzer Recall Over HGB Photometer (2025)

Beckman Coulter recalled the UniCel DxH 690T COULTER Cellular Analysis System configured with the LED HGB Photometer REF C34520. The hematology analyzer may produce erroneously high hemoglobin results on samples with elevated white blood cell counts. Labs should stop using the device immediately and follow Beckman Coulter's recall instructions.

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

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 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

  1. Note if your device is UniCel DxH 690T COULTER with LED HGB Photometer REF C34520
  2. Check for the UDI 15099590729110 and listed model codes
  3. Review Beckman Coulter recall communications for your facility
  4. 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

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

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 Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
UDI: 15099590729110
BD17734
BE12048
BE28105
BF14045
+6 more
Affected States
ALL
Report Date
September 24, 2025
Recall Status
ACTIVE

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