Warning
Foundation Medicine Recalls Protocol Configuration Tool (PCT) software v1.3.0
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1937-2026Medical Device
Foundation Medicine Recalls Protocol Configuration Tool (PCT) software v1.3.0
Foundation Medicine, Inc. · Class II — Moderate Risk
Product Description
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 for Recall
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US distribution to North Carolina and Massachusetts.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. Foundation Medicine, Inc. initiated the recall on March 24, 2026 affecting 10 units. Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Foundation Medicine, Inc. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.