Foundation Medicine, Inc. recalls Protocol Configuration Tool
- Recalling company
- Foundation Medicine, Inc.
- 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.
- Reason
- Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 24, 2026
- Reported
- Apr 29, 2026
- Distribution
- US distribution to North Carolina and Massachusetts.
- Status
- Ongoing
- Quantity
- 10 units
- Lot / codes
- Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)
- Company location
- Cambridge, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1937-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1937-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.