Drug recall
FoundationOne Companion Diagnostic (F1CDx)
FDA recall event 96804 · Class II · Foundation Medicine, Inc.
Key facts
| Event ID | 96804 |
|---|---|
| Recall numbers | Z-1891-2025 |
| Recalling firm | Foundation Medicine, Inc. |
| Product type | Devices |
| Products | FoundationOne Companion Diagnostic (F1CDx) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. |
| Initiation date | Feb 15, 2023 |
| Report date | Jun 11, 2025 |
| 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: