Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FoundationOne CDx test report Recalled by Foundation Medicine, Inc. Due to Identified potential false positive MSI-H on the test...
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 report
Quantity: 8 reports
Why Was This Recalled?
Identified potential false positive MSI-H on the test reports provided to the physicians.
Where Was This Sold?
This product was distributed to 5 states: GA, IN, MA, NC, OH
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