FDA-Device2025-06-11Class II
FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the state of WI.
Affected count
1 unit
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-1891-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief