Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FoundationOne Companion Diagnostic (F1CDx) Recalled by Foundation Medicine, Inc. Due to An incorrect negative claim was identified on the...
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 Companion Diagnostic (F1CDx)
Quantity: 1 unit
Why Was This Recalled?
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
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