FDA-Device2025-05-21Class II
FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine, Inc.
Hazard
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
Sold states
Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.
Affected count
4 units
Manufactured in
150 2nd St, Cambridge, MA, United States
Products
FoundationOne Companion Diagnostic (F1CDx)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1747-2025Don'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