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Foundation Medicine, Inc.

9 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to c recall (Z-2951-2026)Foundation Medicine, Inc.2026-08-14
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within Fo recall (Z-1937-2026)Foundation Medicine, Inc.2026-04-23
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) recall (Z-1927-2026)Foundation Medicine, Inc.2026-04-22
FoundationOne CDx (F1CDx), RAL-0003 version 31.0 recall (Z-0577-2026)Foundation Medicine, Inc.2025-11-21
FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 recall (Z-0578-2026)Foundation Medicine, Inc.2025-11-21
FoundationOne Companion Diagnostic (F1CDx) recall (Z-1890-2025)Foundation Medicine, Inc.2025-05-30
FoundationOne Companion Diagnostic (F1CDx) recall (Z-1891-2025)Foundation Medicine, Inc.2025-05-30
FoundationOne Companion Diagnostic (F1CDx) recall (Z-1747-2025)Foundation Medicine, Inc.2025-05-12
FoundationOne CDx Test Results recall (Z-0649-2019)Foundation Medicine, Inc.2018-12-20

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Every clearance here is in the API, with alerts when new ones post.