Drug recall
Apheresis Platelets, Leukocytes Reduced, Irradiated
FDA recall event 94322 · Class II · Versiti Indiana Inc.
Key facts
| Event ID | 94322 |
|---|---|
| Recall numbers | B-0268-2024 |
| Recalling firm | Versiti Indiana Inc. |
| Product type | Biologics |
| Products | Apheresis Platelets, Leukocytes Reduced, Irradiated |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Leukoreduced Apheresis Platelets, Irradiated, in which the platelet yield did not meet specifications, were distributed. |
| Initiation date | Feb 29, 2024 |
| Report date | Apr 24, 2024 |
| Termination date | Apr 12, 2024 |
| City | Columbus |
| State | OH |
| Country | United States |
| FEI number | 3015387520 |
At a glance
- 1–9 Products in this recall
- 1–9 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: