Drug recall
Apheresis Red Blood Cells, Leukocytes Reduced
FDA recall event 76970 · Class II · OneBlood, Inc.
Key facts
| Event ID | 76970 |
|---|---|
| Recall numbers | B-0544-2017 |
| 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 | Blood product, labeled as leukoreduced, and for which WBC quality control testing was not performed, was distributed. |
| Initiation date | Mar 7, 2017 |
| Report date | May 3, 2017 |
| Termination date | Apr 27, 2017 |
| City | Orlando |
| State | FL |
| Country | United States |
| FEI number | 1072425 |
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: