Drug recall
Apheresis Platelets, PAS, Leukocytes Reduced
FDA recall event 91265 · Class II · OneBlood, Inc.
Key facts
| Event ID | 91265 |
|---|---|
| Recall numbers | B-0074-2023 |
| Recalling firm | OneBlood, Inc. |
| Product type | Biologics |
| Products | Apheresis Platelets, PAS, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Leukoreduced Apheresis Platelets, PAS, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, were distributed. |
| Initiation date | Aug 30, 2022 |
| Report date | Dec 28, 2022 |
| Termination date | Dec 19, 2022 |
| City | Orlando |
| State | FL |
| Country | United States |
| FEI number | 1072425 |
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: