Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)

Recall date

April 9, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1747-2025

FDA classification

Class II

Brand / firm

Foundation Medicine, Inc.

Sold / distributed

Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

FoundationOne Companion Diagnostic (F1CDx)