Drug recall
Red Blood Cells, Leukocytes Reduced
FDA recall event 35401 · Class II · Blood Systems Inc
Key facts
| Event ID | 35401 |
|---|---|
| Recall numbers | B-0249-7 |
| Recalling firm | Blood Systems Inc |
| Product type | Biologics |
| Products | Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood product, collected from a donor who was incorrectly tested for the antibody to the hepatitis B core antigen (anti-HBc), was distributed. |
| Initiation date | Dec 16, 2003 |
| Termination date | Nov 21, 2006 |
| City | Scottsdale |
| Country | United States |
| FEI number | 2084123 |
At a glance
- 1–9 Products in this recall
- 1–9 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