Drug recall
HLA Fusion Software; version 2.0.0 SP4.1, Catalog ID FUSPGR
FDA recall event 65911 · Class II · One Lambda Inc
Key facts
| Event ID | 65911 |
|---|---|
| Recall numbers | B-2326-13 |
| Recalling firm | One Lambda Inc |
| Product type | Biologics |
| Products | HLA Fusion Software; version 2.0.0 SP4.1, Catalog ID FUSPGR |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | HLA Fusion Version 2.0.0-SP4.1, with a defect or glitch causing a conversion error giving incorrect test results for certain beads, was distributed. |
| Initiation date | Jul 26, 2013 |
| Report date | Aug 28, 2013 |
| Termination date | Jan 21, 2014 |
| City | Canoga Park |
| State | CA |
| Country | United States |
| FEI number | 2024375 |
At a glance
- 1–9 Products in this recall
- 1–9 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: