Drug recall
Plateletpheresis, Additive Solution Added; Leukocyte Reduced; Pathogen Reduced
FDA recall event 82766 · Class III · ARUP Laboratories, Inc.
Key facts
| Event ID | 82766 |
|---|---|
| Recall numbers | B-0579-2019 |
| Recalling firm | ARUP Laboratories, Inc. |
| Product type | Biologics |
| Products | Plateletpheresis, Additive Solution Added; Leukocyte Reduced; Pathogen Reduced |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Misbranded plateletpheresis product was distributed. |
| Initiation date | Mar 11, 2019 |
| Report date | May 29, 2019 |
| Termination date | May 23, 2019 |
| City | Sandy |
| State | UT |
| Country | United States |
| FEI number | 1720911 |
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: