Z-2574-2025 Class II Ongoing

Recalled by Beckman Coulter Inc. — Brea, CA

Recall Details

Product Type
Devices
Report Date
September 24, 2025
Initiation Date
August 13, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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

Reason for Recall

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

Distribution Pattern

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.

Code Information

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