Drug recall
Apheresis Red Blood Cells, Leukocytes Reduced
FDA recall event 83703 · Class II · Community Blood Center of Carolinas
Key facts
| Event ID | 83703 |
|---|---|
| Recall numbers | B-0900-2019 |
| Recalling firm | Community Blood Center of Carolinas |
| Product type | Biologics |
| Products | Apheresis Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Leukoreduced Apheresis Red Blood Cells, which were labeled as antigen negative, but were collected from a donor who subsequently tested antigen positive, were distributed. |
| Initiation date | Aug 23, 2019 |
| Report date | Oct 2, 2019 |
| Termination date | Sep 20, 2019 |
| City | Charlotte |
| State | NC |
| Country | United States |
| FEI number | 3004054586 |
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: