—#215646

Product

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

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K193124
Affected lot / code info: 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

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.

Root cause (FDA determination)

Component change control

Action the firm took

On August 13, 2025, Beckman Coulter initiated a "Urgent Medical Device Recall" notification via E-Mail. Beckman Coulter expanded the recall to additional consignees September 25, 2025 Beckman Coulter asked consignees to take the following actions: For specimens with a WBC count > 30 x 103 and = 90 x 103 cells/L, follow the actions listed within the customer letter. For specimens with a WBC count > 90 x 103 cells/L, follow the actions listed within the customer letter. To identify WBC counts > 30 x 103 cells/L, consider implementing decision rules within your Laboratory Information System (LIS), Middleware, or on affected instruments. Consult your Medical Director to determine if a retrospective review of results is warranted. Beckman Coulter recommends posting this letter on or near the affected analyzers Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide them a copy of this letter. Acknowledge receipt of the notification.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

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.

Timeline

Recall initiated: 2025-08-13
Posted by FDA: 2025-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215646. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.