Drug recall
Apheresis Platelets, Leukocytes Reduced
FDA recall event 83121 · Class II · Oklahoma Blood Institute - Sylvan N Goldman Center
Key facts
| Event ID | 83121 |
|---|---|
| Recall numbers | B-0718-2019 |
| Recalling firm | Oklahoma Blood Institute - Sylvan N Goldman Center |
| Product type | Biologics |
| Products | Apheresis Platelets, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Plateletpheresis product in which quality control for white blood cell count testing was not performed, was distributed. |
| Initiation date | Feb 27, 2019 |
| Report date | Jul 10, 2019 |
| Termination date | Jun 28, 2019 |
| City | Oklahoma City |
| State | OK |
| Country | United States |
| FEI number | 1626009 |
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: