Foundation Medicine, Inc.
FDA Regulatory Profile
Foundation Medicine, Inc. has 10 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-2951-2026 · Class II · Jun 10, 2026
- Latest inspection
- Apr 14, 2026 · NAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 10 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 8 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2951-2026 | Class II | Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct… | Jun 10, 2026 |
| Z-1937-2026 | Class II | Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within… | Mar 24, 2026 |
| Z-1927-2026 | Class II | Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) | Mar 20, 2026 |
| Z-1747-2025 | Class II | FoundationOne Companion Diagnostic (F1CDx) | Apr 9, 2025 |
| Z-1890-2025 | Class II | FoundationOne Companion Diagnostic (F1CDx) | Jun 18, 2024 |
| Z-1891-2025 | Class II | FoundationOne Companion Diagnostic (F1CDx) | Feb 15, 2023 |
| Z-0577-2026 | Class II | FoundationOne CDx (F1CDx), RAL-0003 version 31.0 | Nov 8, 2022 |
| Z-0578-2026 | Class II | FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 | Nov 8, 2022 |
| Z-0535-2020 | Class II | FoundationOne CDx test report | Aug 8, 2019 |
| Z-0649-2019 | Class II | FoundationOne CDx Test Results | Oct 31, 2018 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Apr 14, 2026 | Boston, MA | Devices | No Action Indicated (NAI) | 3031598391 |
| Jan 28, 2025 | Boston, MA | Devices | Official Action Indicated (OAI) | 3031598391 |
| Jul 14, 2022 | Cambridge, MA | Devices | No Action Indicated (NAI) | 3010679023 |
| Oct 28, 2019 | Morrisville, NC | Devices | No Action Indicated (NAI) | 3012601180 |
| Jul 17, 2018 | Cambridge, MA | Devices | No Action Indicated (NAI) | 3010679023 |
| Feb 28, 2018 | Cambridge, MA | Devices | Voluntary Action Indicated (VAI) | 3010679023 |
| Sep 23, 2016 | Cambridge, MA | Devices | Voluntary Action Indicated (VAI) | 3010679023 |
| Aug 22, 2016 | Cambridge, MA | Devices | Voluntary Action Indicated (VAI) | 3010679023 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.