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

FDA device recall Z-2574-2025 · posted 2025-09-17 · Open, Classified

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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.

Root cause

Component change control

Status

Open, Classified

Product code

GKZ

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

Date initiated

2025-08-13

Date posted

2025-09-17

Location

Brea, CA

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