Class II
Medical Device Recall: FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine, Inc. · June 18, 2024
Reason for Recall
Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
Distribution
US Nationwide distribution in the state of MI.
States Affected
NATIONWIDE
Quantity Affected
2 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1890-2025
Status: ongoing
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