Beckman Coulter Inc. — UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
⚠️ Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 13, 2025
Worldwide - US Nationwide distribution including in the states of 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 and the countries of 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, Kuwait, Kyrgyzstan, Libya, Lithuania, Mexico, Nepal, Netherlands, New Zealand, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, United States of America, Uruguay, Vietnam.
What's affected?
- Product
- UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
- Brand
- Beckman Coulter Inc.
- Lot code
- UDI: 15099590729110/ Serial Numbers: BD17734, BE12048, BE28105, BF14045, BF23096, BF46236, BG26135, BG50247, BH12019, BH43168
Additional details
UDI: 15099590729110/ Serial Numbers: BD17734, BE12048, BE28105, BF14045, BF23096, BF46236, BG26135, BG50247, BH12019, BH43168
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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