Class II — Foundation Medicine, Inc.
| Recalling firm | Foundation Medicine, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | FoundationOne Companion Diagnostic (F1CDx) |
| Quantity | 4 units |
| Distribution | Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia. |
| Initiated | 2025-04-09 |
| Classified | 2025-05-12 |
| Recall number | Z-1747-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Foundation Medicine, Inc. (Z-1747-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96621/
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