Class 2 Device Recall UniCel DxH 800 COULTER Cellular Analysis System

• Date Initiated by Firm: August 13, 2025
• Date Posted: September 17, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2574-2025
• Recall Event ID: 97464
• 510(K)Number: K193124
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
• 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
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Jennifer cHAU; 714-961-5321
• Manufacturer 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.
• FDA Determined Cause: Component change control
• Action: 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.
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GKZ