Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of RocheLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record. See the Roche group view.
As of Nov 15, 2026, FDA's public records list Foundation Medicine with 10 device recalls. The most recent is a device recall dated Jun 10, 2026: Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 10, 2026 | Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.Class II · Software issue that can cause an increase in spontaneous software closures. | Device recalls |
| Mar 24, 2026 | Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research TrianClass II · Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deploym | Device recalls |
| Mar 20, 2026 | Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)Class II · Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants | Device recalls |
| Apr 9, 2025 | FoundationOne Companion Diagnostic (F1CDx)Class II · Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which wi | Device recalls |
| Jun 18, 2024 | FoundationOne Companion Diagnostic (F1CDx)Class II · Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant informati | Device recalls |
| Feb 15, 2023 | FoundationOne Companion Diagnostic (F1CDx)Class II · An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in | Device recalls |
| Nov 8, 2022 | FoundationOne CDx (F1CDx), RAL-0003 version 31.0Class II · Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via am | Device recalls |
| Nov 8, 2022 | FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0Class II · Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via am | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
