Brand

Foundation Medicine, Inc. Recalls

5 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Foundation Medicine, Inc..

5Total Recalls
0Critical
891Units Affected
Mar 24, 2026Most Recent
All Recalls

Every Foundation Medicine, Inc. Recall

Sorted by most recent. Click any recall for full details.

5 recalls
High RiskFDA
Foundation Medicine, Inc.
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Tr...
Medical Devices·10 affected·Mar 24, 2026
High RiskFDA
Foundation Medicine, Inc.
FoundationOne Companion Diagnostic (F1CDx)
Diagnostic Devices·4 affected·Apr 9, 2025
High RiskFDA
Foundation Medicine, Inc.
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Medical Devices·59 affected·Nov 8, 2022
High RiskFDA
Foundation Medicine, Inc.
FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
Medical Devices·18 affected·Nov 8, 2022
High RiskFDA
Foundation Medicine, Inc.
FoundationOne CDx Test Results
Medical Devices·800 affected·Oct 31, 2018