The FDA has posted 8 enforcement recalls of somatic or germline variant detection system next generation sequencing oncology panel devices since 2025, none of them Class I (most serious). Most recent report: Apr 29, 2026.
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
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.
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.
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
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.
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.
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim.…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System”). Informational only — verify against the FDA before acting.