Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FoundationOne Liquid CDx (F1LCDx) Recalled by Foundation Medicine, Inc. Due to Reports were sent to customers without the companion...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Foundation Medicine, Inc. directly.
Affected Products
FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
Quantity: 18 units (17 US, 1 OUS)
Why Was This Recalled?
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Foundation Medicine, Inc.
Foundation Medicine, Inc. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report