Recall Z-2574-2025— Beckman Coulter Inc.

Name: FDA recall Z-2574-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-13

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2025-08-13. It names one FDA 510(k) clearance: K193124. Product: UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322. Reason: Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-13
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K193124 — Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter·cleared 2020-04-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.