FDA Device recall Z-2572-2025
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
- FDA Device
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478 by Beckman Coulter, citing hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2572-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-13 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Reason
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Identifiers
| code_info | UDI: 15099590701574/ Serial Numbers: BB33238, BB33239, BB42317, BC05150, BC08198, BC10226, BC16320, BC21392, BC23453, B…UDI: 15099590701574/ Serial Numbers: BB33238, BB33239, BB42317, BC05150, BC08198, BC10226, BC16320, BC21392, BC23453, BC25457, BC25465, BC30527, BC32542, BC42721, BC42726, BC49882, BD13219, BD41570, BD46639, BD46643, BD46646, BE01022, BE02044, BE02052, BE04080, BE21222, BE24254, BE24257, BE29334, BE31336, BE33366, BE42455, BE42459, BE46517, BE49539, BE49541, BF10071, BF12126, BF12129, BF18194, BF33377, BF40462, BG04041, BG04042, BG04053, BG05080, BG11182, BG11184, BG11185, BG14195, BG14200, BG14204, BG14208, BG16220, BG16231, BG17238, BG17250, BG17260, BG19283, BG20292, BG20294, BG25395, BG25412, BG25413, BG26435, BG40563, BG45631, BG46635, BH04028, BH04029, BH05051, BH19220, BH24260, BH31328, BD46642, BG22347, BG20307, BD46640, BC32545 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2572-2025%22
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