Drug recall
Apheresis Platelets, Leukocytes Reduced
FDA recall event 77682 · Class II · OneBlood, Inc.
Key facts
| Event ID | 77682 |
|---|---|
| Recall numbers | B-0733-2017, B-0734-2017 |
| Recalling firm | OneBlood, Inc. |
| Product type | Biologics |
| Products | Apheresis Platelets, Leukocytes Reduced, Apheresis Platelets, Leukocytes Reduced, Irradiated |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Apheresis products, in which quality control for white blood count testing was not performed, were distributed. |
| Initiation date | May 22, 2017 |
| Report date | Jul 19, 2017 |
| Termination date | Jul 13, 2017 |
| 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: