Drug recall
Platelets Pheresis
FDA recall event 36212 · Class III · South Bend Medical Foundation
Key facts
| Event ID | 36212 |
|---|---|
| Recall numbers | B-1061-07, B-1062-07, B-1063-07, B-1064-07 |
| Recalling firm | South Bend Medical Foundation |
| Product type | Biologics |
| Products | Platelets Pheresis, Platelets, Pooled, Leukocytes Reduced, Red Blood Cells, Leukocytes Reduced, Red Blood Cells, Leukocytes Reduced, Irradiated |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, improperly tested for hepatitis C virus (HCV) by the Nucleic Acid Test (NAT) method, were distributed. |
| Initiation date | Jul 19, 2006 |
| Termination date | Apr 20, 2007 |
| City | S Bend |
| Country | United States |
| FEI number | 1870308 |
At a glance
- 1–9 Products in this recall
- None 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