Drug recall
Apheresis Platelets, Leukocytes Reduced
FDA recall event 73047 · Class II, Class III · American Red Cross Blood Services
Key facts
| Event ID | 73047 |
|---|---|
| Recall numbers | B-0300-16, B-0301-16, B-0302-16 |
| Recalling firm | American Red Cross Blood Services |
| Product type | Biologics |
| Products | Apheresis Platelets, Leukocytes Reduced, Apheresis Platelets, Leukocytes Reduced, Irradiated |
| Classification | Class II, Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Apheresis products, collected on an instrument undergoing equipment qualification, and for which quality control testing was not performed, were distributed. |
| Initiation date | Nov 24, 2015 |
| Report date | Feb 17, 2016 |
| Termination date | Feb 11, 2016 |
| City | Omaha |
| State | NE |
| Country | United States |
| FEI number | 1973037 |
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: