Drug recall
Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced
FDA recall event 88494 · Class II · OneBlood, Inc.
Key facts
| Event ID | 88494 |
|---|---|
| Recall numbers | B-0588-2021 |
| Recalling firm | OneBlood, Inc. |
| Product type | Biologics |
| Products | Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Leukoreduced Apheresis Platelets, Platelet Additive Solution Added, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, were distributed. |
| Initiation date | Jun 24, 2021 |
| Report date | Sep 8, 2021 |
| Termination date | Sep 2, 2021 |
| 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: