FDA Device recall Z-2573-2025
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
- FDA Device
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520 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-2573-2025 |
| 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 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
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: 15099590729110/ Serial Numbers: BD17734, BE12048, BE28105, BF14045, BF23096, BF46236, BG26135, BG50247, BH12019, BH43168 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Beckman Coulter
- IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997
FDA Device · Class II · 2026-10-21 · Beckman Coulter - DxU 840m Iris, REF: C76947
FDA Device · Class II · 2026-10-21 · Beckman Coulter - DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
FDA Device · Class II · 2026-10-14 · Beckman Coulter - DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3…
FDA Device · Class II · 2026-10-14 · Beckman Coulter - Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C…
FDA Device · Class II · 2026-08-26 · Beckman Coulter
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2573-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.