Drug recall
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
FDA recall event 97464 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 97464 |
|---|---|
| Recall numbers | Z-2572-2025, Z-2573-2025, Z-2574-2025, Z-2575-2025 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858, UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520, UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322, UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Aug 13, 2025 |
| Report date | Sep 24, 2025 |
| City | Brea |
| State | CA |
| Country | United States |
| FEI number | 2050012 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: