Foundation Medicine, Inc. Recalls

7 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (7)

March 24, 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
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
March 20, 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
April 9, 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
June 18, 2024
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
February 15, 2023
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
November 8, 2022
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
November 8, 2022
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

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