Drug recall
Red Blood Cells, Leukocytes Reduced
FDA recall event 85285 · Class III · LifeSouth Community Blood Centers, Inc.
Key facts
| Event ID | 85285 |
|---|---|
| Recall numbers | B-0410-2020 |
| Recalling firm | LifeSouth Community Blood Centers, Inc. |
| Product type | Biologics |
| Products | Red Blood Cells, Leukocytes Reduced |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Red Blood Cell product, which tested positive for an unexpected antibody, was distributed. |
| Initiation date | Feb 4, 2020 |
| Report date | Apr 8, 2020 |
| Termination date | Mar 31, 2020 |
| City | Gainesville |
| State | FL |
| Country | United States |
| FEI number | 1076458 |
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: