Foundation Medicine, Inc. recalls
Every recall we track for Foundation Medicine, Inc. — 10 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
10 recalls since 2017.
All FDA recall records for Foundation Medicine, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 2 | 0 | 2 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 1 | 1 |
| 2026 (to date) | 0 | 0 | 3 | 0 | 3 |
What to do if you have a recalled Foundation Medicine, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Foundation Medicine, Inc. recalls
9 shown- Lower riskMedical device
Foundation Medicine, Inc. recalls Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Foundation Medicine recalls Hamilton Microlab STAR Liquid Handler Protocol Configuration Tool v2.0.0 due to software issues causing spontaneous closures. Affected units include specific equipment IDs for F1CDx and F1LCDx testing.
Foundation MedicineJun 10, 2026 - Lower riskMedical device
Foundation Medicine, Inc. recalls Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)
Foundation Medicine recalls PCT software v1.3.0 for Hamilton AutoLys STAR used in FoundationOneCDx. Potential for spontaneous software closures during autolys protocols after deployment.
Foundation MedicineMar 24, 2026 - Lower riskMedical device
Foundation Medicine, Inc. recalls Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Foundation Medicine recalls Sequencing Agent SEQ0067 (lot 24346, 24386, 24488) due to possible false-positive BARD1 variants in cancer testing. Affected users should contact for details.
Foundation MedicineMar 20, 2026 - UnratedMedical device
Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine recalls F1CDx companion diagnostic due to four reports of clinically relevant variants requiring amendment, one with incorrect negative claim. No remedy specified in recall notice.
Foundation MedicineApr 9, 2025 - Lower riskMedical device
Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine recalls F1CDx companion diagnostic reports with incorrect negative claims. Affected reports may have inaccurate results; contact for remedy.
Foundation MedicineJun 18, 2024 - Lower riskMedical device
Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine recalls FoundationOne Companion Diagnostic (F1CDx) due to incorrect negative claim on claims page. This may affect test accuracy but does not pose immediate safety risks.
Foundation MedicineFeb 15, 2023 - Lower riskMedical device
Foundation Medicine, Inc. recalls FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Foundation Medicine recalls F1CDx version 31.0 due to missing companion diagnostic claims page. Affected units may not function properly without the required claims page.
Foundation MedicineNov 8, 2022 - Lower riskMedical device
Foundation Medicine, Inc. recalls FoundationOne CDx test report
Foundation Medicine recalls specific FoundationOne CDx test reports that may show false positive MSI-H results, which could lead to incorrect cancer treatment decisions.
Foundation MedicineAug 8, 2019 - Lower riskMedical device
Foundation Medicine, Inc. recalls FoundationOne CDx Test Results
Foundation Medicine recalls FoundationOne CDx Test Results for up to 800 physician reports that may have shown incorrect results for a single analyte. Affected reports can be identified by specific specimen numbers.
Foundation MedicineOct 31, 2018
Foundation Medicine, Inc. recall questions
How many recalls has Foundation Medicine, Inc. had?
10 recalls from Foundation Medicine, Inc. are on record with U.S. safety agencies, from 2018–2026.
What is the most recent Foundation Medicine, Inc. recall?
Foundation Medicine, Inc. recalls Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx., dated Jun 10, 2026. Every Foundation Medicine, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Foundation Medicine, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Foundation Medicine, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.