Foundation Medicine, Inc. recalls Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) instal…
- Recall date
- March 24, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1937-2026
- FDA classification
- Class II
- Brand / firm
- Foundation Medicine, Inc.
- Sold / distributed
- US distribution to North Carolina and Massachusetts.
Why it was recalled
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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