Foundation Medicine recalls
Foundation Medicine appears in 10 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-26.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 10 |
|---|---|
| Published | 2018-12-26 to 2026-08-26 |
| By agency | FDA Device (10) |
| By classification | Class II (10) |
| By status | ongoing (8), terminated (2) |
| Distribution named in notices | GA, IN, MA, NC, OH, US |
Recalls
- Hamilton Microlab STAR Liquid Handler
FDA Device · Class II · 2026-08-26 · Foundation Medicine
Reason: Software issue that can cause an increase in spontaneous software closures. - Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Tria…
FDA Device · Class II · 2026-04-29 · Foundation Medicine
Reason: Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR. - Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
FDA Device · Class II · 2026-04-29 · Foundation Medicine
Reason: Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants - FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
FDA Device · Class II · 2025-12-03 · Foundation Medicine
Reason: 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. - FoundationOne CDx (F1CDx), RAL-0003 version 31.0
FDA Device · Class II · 2025-12-03 · Foundation Medicine
Reason: 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. - FoundationOne Companion Diagnostic (F1CDx)
FDA Device · Class II · 2025-06-11 · Foundation Medicine
Reason: 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. - FoundationOne Companion Diagnostic (F1CDx)
FDA Device · Class II · 2025-06-11 · Foundation Medicine
Reason: 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. - FoundationOne Companion Diagnostic (F1CDx)
FDA Device · Class II · 2025-05-21 · Foundation Medicine
Reason: 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… - FoundationOne CDx test report
FDA Device · Class II · 2019-12-04 · Foundation Medicine
Reason: Identified potential false positive MSI-H on the test reports provided to the physicians. - FoundationOne CDx Test Results
FDA Device · Class II · 2018-12-26 · Foundation Medicine
Reason: An incorrect test result for a single analyte may have been reported for up to 800 physician reports