Drug recall
Red Blood Cells, Leukocytes Reduced
FDA recall event 35837 · Class III · Bergen Comm Reg Blood Center
Key facts
| Event ID | 35837 |
|---|---|
| Recall numbers | B-1725-6 |
| Recalling firm | Bergen Comm Reg Blood Center |
| Product type | Biologics |
| Products | Red Blood Cells, Leukocytes Reduced |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood product, which tested negative for Hepatitis B Surface antigen (HBsAg) and for the antibody to Hepatitis B core antigen (anti-HBc), but was collected from a donor who previously tested positive… |
| Initiation date | Mar 23, 2005 |
| Termination date | Sep 5, 2006 |
| City | Paramus |
| Country | United States |
| FEI number | 2275064 |
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