Drug recall
Red Blood Cells, Leukocytes Reduced
FDA recall event 84556 · Class II · OneBlood, Inc.
Key facts
| Event ID | 84556 |
|---|---|
| Recall numbers | B-0243-2020 |
| 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 | Red Blood Cell product in which routine testing/testing performed, interpreted, documented, or labeled incorrectly, was distributed. |
| Initiation date | Nov 14, 2019 |
| Report date | Jan 22, 2020 |
| Termination date | Jan 15, 2020 |
| City | Fort Lauderdale |
| State | FL |
| Country | United States |
| FEI number | 1077496 |
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: