Drug recall
Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced
FDA recall event 85370 · Class II · American National Red Cross (The) Carolinas Region
Key facts
| Event ID | 85370 |
|---|---|
| Recall numbers | B-0427-2020 |
| Recalling firm | American National Red Cross (The) Carolinas Region |
| Product type | Biologics |
| Products | Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Plateletpheresis product, for which the pathogen reduction process was not performed in accordance with specifications, was distributed. |
| Initiation date | Feb 13, 2020 |
| Report date | Apr 15, 2020 |
| Termination date | Apr 9, 2020 |
| City | Charlotte |
| State | NC |
| Country | United States |
| FEI number | 1073007 |
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: