Drug recall
Platelets, Pathogen Reduced
FDA recall event 86730 · Class II · Bergen Comm Reg Blood Center
Key facts
| Event ID | 86730 |
|---|---|
| Recall numbers | B-0068-2021 |
| Recalling firm | Bergen Comm Reg Blood Center |
| Product type | Biologics |
| Products | Platelets, Pathogen Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Platelet products, collected from donors who gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed. |
| Initiation date | Oct 6, 2020 |
| Report date | Dec 9, 2020 |
| Termination date | Dec 1, 2020 |
| City | Allendale |
| 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: