Foundation Medicine, Inc. recalls

All Foundation Medicine, Inc. recalls we track from FDA, CPSC and NHTSA data. Categories: medical devices (8).

8 recalls published between May 21, 2025 and August 26, 2026. Most common issues: software (2).

• Hamilton Microlab STAR Liquid Handler recall
  FDA August 26, 2026 · Foundation Medicine, Inc. · Class II
• Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys… recall
  FDA April 29, 2026 · Foundation Medicine, Inc. · Class II
• Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) recall
  FDA April 29, 2026 · Foundation Medicine, Inc. · Class II
• FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 recall
  FDA December 3, 2025 · Foundation Medicine, Inc. · Class II
• FoundationOne CDx (F1CDx), RAL-0003 version 31.0 recall
  FDA December 3, 2025 · Foundation Medicine, Inc. · Class II
• FoundationOne Companion Diagnostic (F1CDx) recall
  FDA June 11, 2025 · Foundation Medicine, Inc. · Class II
• FoundationOne Companion Diagnostic (F1CDx) recall
  FDA June 11, 2025 · Foundation Medicine, Inc. · Class II
• FoundationOne Companion Diagnostic (F1CDx) recall
  FDA May 21, 2025 · Foundation Medicine, Inc. · Class II