Foundation Medicine, Inc. recalls Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) install

Recalled April 29, 2026 · FDA recall Z-1937-2026 · Foundation Medicine

Hazard

Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR. · FDA Class II

Units

10 units

Sold at

US distribution to North Carolina and Massachusetts.

Description

Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.

Product

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.

Manufacturer(s)

Foundation Medicine, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →