Drug recall
Pooled Cryoprecipitated AHF
FDA recall event 86813 · Class II · Innovative Blood Resources d.b.a. Nebraska Community Blood Bank
Key facts
| Event ID | 86813 |
|---|---|
| Recall numbers | B-0077-2021, B-0078-2021 |
| Recalling firm | Innovative Blood Resources d.b.a. Nebraska Community Blood Bank |
| Product type | Biologics |
| Products | Pooled Cryoprecipitated AHF, Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Blood products, collected from a donor who previously tested positive for the antibody to Hepatitis B core Antigen on more than one occasion and not properly re-entered, were distributed. |
| Initiation date | May 6, 2020 |
| Report date | Dec 9, 2020 |
| Termination date | Dec 2, 2020 |
| City | Lincoln |
| State | NE |
| Country | United States |
| FEI number | 1970753 |
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: