FDA DeviceClass IINotable

FDA Recall: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOn

Date: 2026-04-29
Brand: Foundation Medicine, Inc.
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

10 units

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