Drug recall
Apheresis Red Blood Cells, Leukocytes Reduced
FDA recall event 91901 · Class II · OneBlood, Inc.
Key facts
| Event ID | 91901 |
|---|---|
| Recall numbers | B-0287-2023 |
| Recalling firm | OneBlood, Inc. |
| Product type | Biologics |
| Products | Apheresis Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Apheresis Red Blood Cell products, for which quality control for residual white blood cell count was not performed, were distributed. |
| Initiation date | Feb 14, 2023 |
| Report date | Apr 5, 2023 |
| Termination date | Mar 29, 2023 |
| City | St Petersburg |
| State | FL |
| Country | United States |
| FEI number | 1070196 |
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: