Drug recall
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI…
FDA recall event 79437 · Class II · Life Technologies Corporation
Key facts
| Event ID | 79437 |
|---|---|
| Recall numbers | Z-1279-2018 |
| Recalling firm | Life Technologies Corporation |
| Product type | Devices |
| Products | Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens. |
| Initiation date | Dec 4, 2017 |
| Report date | Apr 11, 2018 |
| Termination date | Nov 10, 2020 |
| City | Frederick |
| State | MD |
| Country | United States |
| FEI number | 3003335080 |
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: