Drug recall
Red Blood Cells, Leukocytes Reduced
FDA recall event 78205 · Class II · Bergen Comm Reg Blood Center
Key facts
| Event ID | 78205 |
|---|---|
| Recall numbers | B-0045-2018 |
| Recalling firm | Bergen Comm Reg Blood Center |
| Product type | Biologics |
| Products | Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, untested but labeled as negative for Zika virus, were distributed. |
| Initiation date | Aug 31, 2016 |
| Report date | Oct 25, 2017 |
| Termination date | Oct 19, 2017 |
| City | Montvale |
| State | NJ |
| 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 · Source date: