healthClass IIRecalled on Sep 24, 2025

UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

🔢 N/A

Sold At: Beckman Coulter Inc.(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.)

Recall #: FDA-DEVICE-Z-2574-2025

Source: FDA-ENFORCEMENT

UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer  REFs:B24802, 629029, B63322

Product Identification

Lot/Batch Codes:
UDIs: 15099590672423, 15099590381646, 15099590687922/ Serial Numbers: AT38527, AU02008, AU10078, AV28630, AW13187, AW29123, BC18100, RBB03201, AW43276, AY06074, AY06092, AY41556, AY43605, AZ02030, AZ03041, AZ18245, AZ22329, AZ39513, AZ46681, BA03048, BA03050, BA03055, BA03060, BA07061, BA07062, BA13227, BA15245, BA27414, BB16181, BB29286, BC08036, BC18099, AZ25376, BB25262, BB25261, BA25393

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Summary

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

What to do next

  • 1Stop using this product - may cause temporary or medically reversible health problems
  • 2Check with retailer or manufacturer for recall status and remedy options
  • 3Contact Beckman Coulter Inc. for return or refund information
  • 4Visit the official FDA recall page for complete details

Summaries only; always follow the official notice.