Drug recall
Apheresis Red Blood Cells, Leukocytes Reduced
FDA recall event 82308 · Class II · LifeSouth Community Blood Centers, Inc.
Key facts
| Event ID | 82308 |
|---|---|
| Recall numbers | B-0384-2019 |
| Recalling firm | LifeSouth Community Blood Centers, Inc. |
| Product type | Biologics |
| Products | Apheresis Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Apheresis product in which quality control for residual WBC count was not performed, was distributed. |
| Initiation date | Feb 8, 2019 |
| Report date | Mar 27, 2019 |
| Termination date | Mar 18, 2019 |
| City | Dunwoody |
| State | GA |
| Country | United States |
| FEI number | 1000512072 |
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: