Drug recall
Apheresis Platelets, Leukocytes Reduced
FDA recall event 80809 · Class II · American National Red Cross (The) - North Central Region
Key facts
| Event ID | 80809 |
|---|---|
| Recall numbers | B-0804-2018 |
| Recalling firm | American National Red Cross (The) - North Central Region |
| Product type | Biologics |
| Products | Apheresis Platelets, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Platelet components, for which the pathogen reduction process was not performed in accordance with specifications, were distributed. |
| Initiation date | Jun 12, 2018 |
| Report date | Sep 26, 2018 |
| Termination date | Sep 17, 2018 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 2173038 |
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: