FoundationOne Companion Diagnostic — Class II medical device recall Z-1747-2025
Ongoing recall by Foundation Medicine, Inc., reported 2025-05-21, distributed nationwide. Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) o
| Recall number | Z-1747-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Foundation Medicine, Inc., Cambridge, MA, United States |
| Recall initiated | 2025-04-09 |
| Classified | 2025-05-12 |
| Reported by FDA | 2025-05-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | RU |
| Quantity | 4 units |
Product
FoundationOne Companion Diagnostic (F1CDx)
Reason for recall
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
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-1747-2025. 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.