Foundation Medicine, Inc. recalls

3 recalls on record · latest: March 24, 2026

Official U.S. recall history for Foundation Medicine, Inc., compiled from official government records.

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Foundation Medicine, Inc. recalls Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) instal…

March 24, 2026 · Medical device recalls Moderate risk Potential for spontaneous closures of Hamilton HxRunControl software during exe…

Foundation Medicine, Inc. recalls Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

March 20, 2026 · Medical device recalls Moderate risk Possible increase in phasing, potentially resulting in false-positive BARD1 spl…

Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)

April 9, 2025 · Medical device recalls Moderate risk Four (4) total reports were sent to customers with clinically relevant variants…