Drug recall
Apheresis Platelets, Leukocytes Reduced
FDA recall event 94757 · Class II · Versiti Indiana Inc
Key facts
| Event ID | 94757 |
|---|---|
| Recall numbers | B-0366-2024, B-0367-2024 |
| Recalling firm | Versiti Indiana Inc |
| Product type | Biologics |
| Products | Apheresis Platelets, Leukocytes Reduced, Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Leukoreduced Platelets products, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, were distributed. |
| Initiation date | Mar 27, 2024 |
| Report date | Jul 17, 2024 |
| Termination date | Jul 5, 2024 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 1873403 |
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: