Foundation Medicine recalls

Foundation Medicine appears in 10 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-26.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Hamilton Microlab STAR Liquid Handler
  FDA Device · Class II · 2026-08-26 · Foundation Medicine
• Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Tria…
  FDA Device · Class II · 2026-04-29 · Foundation Medicine
• Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
  FDA Device · Class II · 2026-04-29 · Foundation Medicine
• FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
  FDA Device · Class II · 2025-12-03 · Foundation Medicine
• FoundationOne CDx (F1CDx), RAL-0003 version 31.0
  FDA Device · Class II · 2025-12-03 · Foundation Medicine
• FoundationOne Companion Diagnostic (F1CDx)
  FDA Device · Class II · 2025-06-11 · Foundation Medicine
• FoundationOne Companion Diagnostic (F1CDx)
  FDA Device · Class II · 2025-06-11 · Foundation Medicine
• FoundationOne Companion Diagnostic (F1CDx)
  FDA Device · Class II · 2025-05-21 · Foundation Medicine
• FoundationOne CDx test report
  FDA Device · Class II · 2019-12-04 · Foundation Medicine
• FoundationOne CDx Test Results
  FDA Device · Class II · 2018-12-26 · Foundation Medicine