FDAHealthMarch 24, 2026

Foundation Medicine, Inc. — Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment ID

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

Is this relevant to me?

Geography: US
Source agency: FDA
Category: Health
Published: March 24, 2026

US distribution to North Carolina and Massachusetts.

What's affected?

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.
Brand: Foundation Medicine, Inc.
Lot code: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)

Additional details

Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 10 units.

View original FDA notice →

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