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 | Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants |
| Product | Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) |
| Quantity | 163 units |
| Distribution | US Nationwide distribution in the states of Massachusetts and North Carolina. |
| Initiated | 2026-03-20 |
| Classified | 2026-04-22 |
| Recall number | Z-1927-2026 |
| 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-1927-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98625/
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