Drug recall
uTYPE Dx v1.0 HLA Sequence Analysis Software, Catalog ID 539993
FDA recall event 78519 · Class III · One Lambda Inc
Key facts
| Event ID | 78519 |
|---|---|
| Recall numbers | B-0132-2018 |
| Recalling firm | One Lambda Inc |
| Product type | Biologics |
| Products | uTYPE Dx v1.0 HLA Sequence Analysis Software, Catalog ID 539993 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | HLA Sequence Analysis Software (v1.0), with a defect or glitch, was distributed. |
| Initiation date | Nov 9, 2017 |
| Report date | Nov 29, 2017 |
| Termination date | Jan 9, 2018 |
| 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: