Recalling firm
Foundation Medicine, Inc.
Product type
Device
Status
Ongoing
Report date
2026-04-29
Distribution
US distribution to North Carolina and Massachusetts.
Firm state
MA
Product quantity
10 units
Initiated by
Voluntary: Firm initiated
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.
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.
Code / lot info
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.