Drug recall
FoundationOne CDx Test Results
FDA recall event 81614 · Class II · Foundation Medicine, Inc.
Key facts
| Event ID | 81614 |
|---|---|
| Recall numbers | Z-0649-2019 |
| Recalling firm | Foundation Medicine, Inc. |
| Product type | Devices |
| Products | FoundationOne CDx Test Results |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An incorrect test result for a single analyte may have been reported for up to 800 physician reports |
| Initiation date | Oct 31, 2018 |
| Report date | Dec 26, 2018 |
| Termination date | Apr 17, 2020 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3010679023 |
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: