Class II
Medical Device Recall: FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine, Inc. · February 15, 2023
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of WI.
States Affected
NATIONWIDE
Quantity Affected
1 unit
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1891-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.