Drug recall
Platelets Pheresis, Leukocytes Reduced
FDA recall event 28348 · Class II · Central Indiana Regional Blood Center, Inc
Key facts
| Event ID | 28348 |
|---|---|
| Recall numbers | B-0935-4 |
| Recalling firm | Central Indiana Regional Blood Center, Inc |
| Product type | Biologics |
| Products | Platelets Pheresis, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed. |
| Initiation date | Sep 29, 2003 |
| Termination date | Apr 13, 2004 |
| City | Indianapolis |
| Country | United States |
| FEI number | 1873403 |
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