Drug recall
Reagent Red Blood Cells
FDA recall event 95385 · Class III · Immucor, Inc.
Key facts
| Event ID | 95385 |
|---|---|
| Recall numbers | B-0510-2024 |
| Recalling firm | Immucor, Inc. |
| Product type | Biologics |
| Products | Reagent Red Blood Cells |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Immucor has detected that some kits of Panocell-10, Ficin treated exhibit an unexpected dark color (hemolysis) and darkening of the red blood cells. Immucor has confirmed fungal growth in the vials… |
| Initiation date | Jun 25, 2024 |
| Report date | Oct 23, 2024 |
| Termination date | Jan 22, 2025 |
| City | Peachtree Corners |
| State | GA |
| Country | United States |
| FEI number | 1034569 |
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: