Drug recall
Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced
FDA recall event 95108 · Class II · Department of Defense - Navy
Key facts
| Event ID | 95108 |
|---|---|
| Recall numbers | B-0469-2024 |
| Recalling firm | Department of Defense - Navy |
| Product type | Biologics |
| Products | Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Leukoreduced Apheresis Platelets, Pathogen Reduced, which were labeled as leukocytes reduced but were tested with expired reagents to verify white blood cell count, were distributed. |
| Initiation date | Apr 3, 2024 |
| Report date | Aug 28, 2024 |
| Termination date | Aug 19, 2024 |
| City | Bethesda |
| State | MD |
| Country | United States |
| FEI number | 1176560 |
At a glance
- 1–9 Products in this recall
- None 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: