Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FoundationOne CDx Test Results Recalled by Foundation Medicine, Inc. Due to An incorrect test result for a single analyte...
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 CDx Test Results
Quantity: 800 reports
Why Was This Recalled?
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
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