Foundation Medicine, Inc.

Foundation Medicine, Inc.: 3 recalls listed since April 2026 across FDA.

By year

20263

By agency

FDA3

By category

Medical Device3

All recalls (3)

Device Recall
FDA•Aug 14, 2026MODERATE
Hamilton Microlab STAR PCT Software
Foundation Medicine recalls Hamilton Microlab STAR PCT v2.0.0 over spontaneous software closures.
FDA•Apr 23, 2026MODERATE
Hamilton AutoLys STAR Protocol Configuration Tool Software
Foundation Medicine recalls PCT software v1.3.0 for Hamilton AutoLys STAR due to risk of spontaneous software closures during protocol execution.
FDA•Apr 22, 2026MODERATE
FoundationOne CDx Sequencing Agent SEQ0067
Foundation Medicine is recalling Sequencing Agent SEQ0067 component of FoundationOne CDx due to possible false-positive BARD1 variants.