Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2574-2025 — UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

U.S. FDA — Device Enforcement · United States · 2025-08-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2574-2025
Date of alert
2025-08-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15099590672423
Reported risk: Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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