Hamilton AutoLys STAR Protocol Configuration Tool Software
Foundation Medicine recalls PCT software v1.3.0 for Hamilton AutoLys STAR due to risk of spontaneous software closures during protocol execution.
If you operate Hamilton AutoLys STAR equipment with PCT software v1.3.0 at the affected Research Triangle Park laboratory, contact Foundation Medicine immediately for a software update or patch to prevent spontaneous HxRunControl closures during protocol execution.
Why it was recalled
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
How to identify it
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.
Where it was sold
Distributed in US-MA, US-NC.
Official source
Other recent recalls from Foundation Medicine, Inc.
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification