Drug recall
Red Blood Cells, Leukocytes Reduced
FDA recall event 97342 · Class II · New York Blood Center Inc.
Key facts
| Event ID | 97342 |
|---|---|
| Recall numbers | B-0395-2025, B-0396-2025, B-0397-2025 |
| Recalling firm | New York Blood Center Inc. |
| Product type | Biologics |
| Products | Red Blood Cells, Leukocytes Reduced, Red Blood Cells, Leukocytes Reduced, Irradiated, Whole Blood |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Red Blood Cells, Leukocytes Reduced, Irradiated, which were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count, were distributed., Red Blood Cells, Leukocytes Reduced, which were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count, were distributed., Whole Blood, which was labeled as leukocytes reduced but failed the monthly… |
| Initiation date | Sep 20, 2024 |
| Report date | Aug 6, 2025 |
| Termination date | Jul 28, 2025 |
| City | Rye |
| State | NY |
| Country | United States |
| FEI number | 2473015 |
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: