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 | Terminated |
| Reason | An incorrect test result for a single analyte may have been reported for up to 800 physician reports |
| Product | FoundationOne CDx Test Results |
| Quantity | 800 reports |
| Distribution | US nationwide |
| Initiated | 2018-10-31 |
| Classified | 2018-12-20 |
| Terminated | 2020-04-17 |
| Recall number | Z-0649-2019 |
| 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-0649-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81614/
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