Drug recall
Red Blood Cells, Leukocytes Reduced
FDA recall event 91544 · Class II · OneBlood, Inc.
Key facts
| Event ID | 91544 |
|---|---|
| Recall numbers | B-0162-2023 |
| Recalling firm | OneBlood, Inc. |
| Product type | Biologics |
| Products | Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Leukoreduced Red Blood Cells, where transfusion-transmitted infection testing was performed and/or interpreted incorrectly, were distributed. |
| Initiation date | Jul 21, 2022 |
| Report date | Feb 8, 2023 |
| Termination date | Feb 2, 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: