Foundation Medicine, Inc.
Cambridge, MA, US
FOUNDATION MEDICINE, INC. appears in FDA device records in Cambridge, MA. FDA records list no 510(k) clearances, 98 PMA records and 2 registered establishments. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010679023 | 3010679023 | FOUNDATION MEDICINE, INC. | 150 Second St, Cambridge, MA 02141 US | 2026 | |
| 3031598391 | 3031598391 | FOUNDATION MEDICINE, INC. | 400 Summer St, Boston, MA 02210 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2951-2026 | Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx. | Software issue that can cause an increase in spontaneous software closures. | Class II | Open, Classified | |
| Z-1937-2026 | Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995. | Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR. | Class II | Open, Classified | |
| Z-1927-2026 | Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) | Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants | Class II | Open, Classified | |
| Z-1747-2025 | FoundationOne Companion Diagnostic (F1CDx) | 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. | Class II | Open, Classified | |
| Z-1890-2025 | FoundationOne Companion Diagnostic (F1CDx) | Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports. | Class II | Open, Classified | |
| Z-1891-2025 | FoundationOne Companion Diagnostic (F1CDx) | An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. | Class II | Open, Classified | |
| Z-0578-2026 | FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 | Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence. | Class II | Open, Classified | |
| Z-0577-2026 | FoundationOne CDx (F1CDx), RAL-0003 version 31.0 | Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence. | Class II | Open, Classified | |
| Z-0535-2020 | FoundationOne CDx test report | Identified potential false positive MSI-H on the test reports provided to the physicians. | Class II | Terminated | |
| Z-0649-2019 | FoundationOne CDx Test Results | An incorrect test result for a single analyte may have been reported for up to 800 physician reports | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain