Beckman Coulter Inc. recalls UniCel DxH 800 COULTER Cellular Analysis System

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-2574-2025
• FDA 510(k) clearance · K193124The device's official FDA premarket clearance record
• FDA device classification · GKZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.5220The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Beckman Coulter Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.