AllClear
PricingSign in
FDAFebruary 15, 2023device

FoundationOne Companion Diagnostic (F1CDx)

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

foundation medicinefoundation

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →