FDA-Device2025-06-11Class II
FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the state of MI.
Affected count
2 units
Manufactured in
150 2nd St, N/A, Cambridge, MA, United States
Products
FoundationOne Companion Diagnostic (F1CDx)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1890-2025Don't want to check this manually?
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