Recall Z-1937-2026— Foundation Medicine, Inc.
Class II · Ongoing
Class II FDA medical device recall by Foundation Medicine, Inc., initiated 2026-03-24. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Foundation Medicine, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-24
- Firm location
- Cambridge, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.