Foundation Medicine, Inc.: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Recalling firm
- 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 III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-24
- Status
- Open, Classified
- Distribution
- US distribution to North Carolina and Massachusetts.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/768b9bb6-e194-4a33-99af-620ae5711023