Drug recall
Apheresis Platelets, Leukocytes Reduced
FDA recall event 95005 · Class II · Versiti Illinois Inc
Key facts
| Event ID | 95005 |
|---|---|
| Recall numbers | B-0396-2024 |
| Recalling firm | Versiti Illinois Inc |
| Product type | Biologics |
| Products | Apheresis Platelets, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Leukoreduced platelet product, for which platelet concentration did not meet specifications, was distributed. |
| Initiation date | Apr 22, 2024 |
| Report date | Aug 21, 2024 |
| Termination date | Aug 9, 2024 |
| City | Aurora |
| State | IL |
| Country | United States |
| FEI number | 1470274 |
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: