Drug recall
Platelets Leukocytes Reduced
FDA recall event 66615 · Class II · OneBlood, Inc.
Key facts
| Event ID | 66615 |
|---|---|
| Recall numbers | B-0120-14, B-0121-14, B-0122-14 |
| Recalling firm | OneBlood, Inc. |
| Product type | Biologics |
| Products | Platelets Leukocytes Reduced, Platelets Pheresis Leukocytes Reduced, Red Blood Cells Leukocytes Reduced Irradiated |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. |
| Initiation date | Sep 24, 2013 |
| Report date | Nov 20, 2013 |
| Termination date | Nov 14, 2013 |
| City | Hialeah |
| State | FL |
| Country | United States |
| FEI number | 1072594 |
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: