Drug recall
Platelets Pheresis Leukocytes Reduced
FDA recall event 56466 · Class II · American National Red Cross (The)
Key facts
| Event ID | 56466 |
|---|---|
| Recall numbers | B-1308-13, B-1309-13 |
| Recalling firm | American National Red Cross (The) |
| Product type | Biologics |
| Products | Platelets Pheresis Leukocytes Reduced, Platelets Pheresis Leukocytes Reduced Irradiated |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, which were labeled as leukoreduced, but were collected on an apheresis machine that failed quality control testing for leukoreduction, were distributed. |
| Initiation date | Jun 29, 2010 |
| Report date | Apr 3, 2013 |
| Termination date | Apr 29, 2013 |
| City | Tulsa |
| State | OK |
| Country | United States |
| FEI number | 1673040 |
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: