FoundationOne Companion Diagnostic — Class II medical device recall Z-1891-2025
Ongoing recall by Foundation Medicine, Inc., reported 2025-06-11, distributed nationwide. An incorrect negative claim was identified on the claims page; the device variant information was displayed co
| Recall number | Z-1891-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Foundation Medicine, Inc., Cambridge, MA, United States |
| Recall initiated | 2023-02-15 |
| Classified | 2025-05-30 |
| Reported by FDA | 2025-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
Product
FoundationOne Companion Diagnostic (F1CDx)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1891-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.