Drug recall
Red Blood Cells, Leukocytes Reduced
FDA recall event 92109 · Class II · American National Red Cross, Penn Jersey Region
Key facts
| Event ID | 92109 |
|---|---|
| Recall numbers | B-0355-2023, B-0356-2023 |
| Recalling firm | American National Red Cross, Penn Jersey Region |
| Product type | Biologics |
| Products | Red Blood Cells, Leukocytes Reduced, Whole Blood, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Blood Products, which were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count, were distributed. |
| Initiation date | Oct 31, 2022 |
| Report date | Apr 26, 2023 |
| Termination date | Apr 18, 2023 |
| City | Philadelphia |
| State | PA |
| Country | United States |
| FEI number | 2573021 |
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: