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Foundation Medicine, Inc.

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1747-2025Class IIFoundationOne Companion Diagnostic (F1CDx)April 9, 2025
Z-1890-2025Class IIFoundationOne Companion Diagnostic (F1CDx)June 18, 2024
Z-1891-2025Class IIFoundationOne Companion Diagnostic (F1CDx)February 15, 2023
Z-0578-2026Class IIFoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0November 8, 2022
Z-0577-2026Class IIFoundationOne CDx (F1CDx), RAL-0003 version 31.0November 8, 2022
Z-0535-2020Class IIFoundationOne CDx test reportAugust 8, 2019
Z-0649-2019Class IIFoundationOne CDx Test ResultsOctober 31, 2018