⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Is Foundation Medicine recalled?

Foundation Medicine recalls - full list & free alerts

Official U.S. agency records list 5 recalls involving Foundation Medicine in the last 12 months, most recently on 2026-08-26. Check each official notice for the exact products, lot codes and dates affected.

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Recalls (5)

Foundation Medicine, Inc.: Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Medical DevicesFDA (device) · 2026-08-26 · Class II
Foundation Medicine, Inc.: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Medical DevicesFDA (device) · 2026-04-29 · Class II
Foundation Medicine, Inc.: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Trian
Medical DevicesFDA (device) · 2026-04-29 · Class II
Foundation Medicine, Inc.: FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Medical DevicesFDA (device) · 2025-12-03 · Class II
Foundation Medicine, Inc.: FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
Medical DevicesFDA (device) · 2025-12-03 · Class II
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