Data / Medical devices / United States / Foundation Medicine, Inc.
Foundation Medicine, Inc.: FDA-registered device maker in Cambridge, MA, United States, 4 PMA approvals
Foundation Medicine, Inc. is registered with the FDA (registration 3010679023) in Cambridge, MA, United States. It lists 1 device type. The FDA files 4 PMA approvals under its listings, the newest dated November 6, 2020. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010679023
- Address
- 150 Second St 1st Floor, Cambridge, MA, United States, 02141
- Owner or operator
- Foundation Medicine, Inc. (10053707)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 15, 2017
- Registered through
- 2026
- Brand names listed
- FoundationOne CDx, FoundationOne® Liquid CDx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | PQP | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 6, 2020 | P200016 | FoundationOne Liquid CDx | PQP | 2 | March 8, 2023 | accessdata.fda.gov |
| October 26, 2020 | P200006 | FoundationOne Liquid CDx (F1 Liquid CDx) | PQP | 4 | March 8, 2023 | accessdata.fda.gov |
| August 26, 2020 | P190032 | FoundationOne Liquid CDx (F1 Liquid CDx) | PQP | 27 | September 18, 2026 | accessdata.fda.gov |
| November 30, 2017 | P170019 | FoundationOne CDx | PQP | 61 | September 16, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 10, 2026 | 99268 | Class II | Ongoing | 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. | accessdata.fda.gov |
| March 24, 2026 | 98640 | Class II | Ongoing | 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. | accessdata.fda.gov |
| March 20, 2026 | 98625 | Class II | Ongoing | Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) | Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants | accessdata.fda.gov |
| April 9, 2025 | 96621 | Class II | Ongoing | 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. | accessdata.fda.gov |
| June 18, 2024 | 96802 | Class II | Ongoing | 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. | accessdata.fda.gov |
| February 15, 2023 | 96804 | Class II | Ongoing | 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. | accessdata.fda.gov |
| November 8, 2022 | 97854 | Class II | Ongoing | 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. | accessdata.fda.gov |
| August 8, 2019 | 83729 | Class II | Terminated | FoundationOne CDx test report | Identified potential false positive MSI-H on the test reports provided to the physicians. | accessdata.fda.gov |
| October 31, 2018 | 81614 | Class II | Terminated | FoundationOne CDx Test Results | An incorrect test result for a single analyte may have been reported for up to 800 physician reports | accessdata.fda.gov |
Compare with other makers
Updated August 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.