FDAMarch 24, 2026device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
What to do
FDA enforcement status: Ongoing
Brands named
foundation medicinefoundation
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)2026-03-20
- CPSCProfessional's Choice Sports Medicine Products Recalls Equine Bits Due to Fall Hazard2025-06-26
- FDABostonSight PROSE Lens.2025-06-10
- FDABostonSight SCLERAL Lens2025-06-10
- FDAFoundationOne Companion Diagnostic (F1CDx)2025-04-09
- FDAFoundationOne Companion Diagnostic (F1CDx)2024-06-18
- FDAAFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)2023-12-22
- FDAAFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)2023-12-22
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