Drug recall
Whole Blood Leukocytes Reduced
FDA recall event 78628 · Class II · Central Texas Regional Blood & Tissue Center
Key facts
| Event ID | 78628 |
|---|---|
| Recall numbers | B-0184-2018 |
| Recalling firm | Central Texas Regional Blood & Tissue Center |
| Product type | Biologics |
| Products | Whole Blood Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood product, labeled as leukoreduced but failed quality control testing for WBC count, was distributed. |
| Initiation date | Oct 9, 2017 |
| Report date | Dec 27, 2017 |
| Termination date | Dec 21, 2017 |
| City | Austin |
| State | TX |
| Country | United States |
| FEI number | 1671794 |
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: