Drug recall
Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced
FDA recall event 92982 · Class II · American Red Cross Blood Services Tennessee Valley Region
Key facts
| Event ID | 92982 |
|---|---|
| Recall numbers | B-0629-2023 |
| Recalling firm | American Red Cross Blood Services Tennessee Valley Region |
| Product type | Biologics |
| Products | Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Plateletpheresis product, for which quality control for white blood cell count testing was not performed, was distributed. |
| Initiation date | Aug 3, 2023 |
| Report date | Sep 20, 2023 |
| Termination date | Sep 8, 2023 |
| City | Nashville |
| State | TN |
| Country | United States |
| FEI number | 1073006 |
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: