Drug recall
Apheresis Red Blood Cells, Leukocytes Reduced
FDA recall event 83475 · Class II · OneBlood, Inc.
Key facts
| Event ID | 83475 |
|---|---|
| Recall numbers | B-0831-2019 |
| Recalling firm | OneBlood, Inc. |
| Product type | Biologics |
| Products | Apheresis Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Apheresis Red Blood Cells, which were labeled as leukoreduced but were not tested to verify white blood cell count, were distributed. |
| Initiation date | Jul 3, 2019 |
| Report date | Aug 28, 2019 |
| Termination date | Aug 19, 2019 |
| City | St Petersburg |
| State | FL |
| Country | United States |
| FEI number | 1070196 |
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: