Drug recall
Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced
FDA recall event 91397 · Class II · American Red Cross Blood Services
Key facts
| Event ID | 91397 |
|---|---|
| Recall numbers | B-0092-2023 |
| Recalling firm | American Red Cross Blood Services |
| 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 not tested to verify white blood cell count, were distributed. |
| Initiation date | Sep 30, 2022 |
| Report date | Jan 11, 2023 |
| Termination date | Dec 30, 2022 |
| City | Saint Louis |
| State | MO |
| Country | United States |
| FEI number | 1973035 |
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: