Beckman Coulter Inc. recalls UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

Recall date

August 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2574-2025

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

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, B…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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