Class II

Medical Device Recall: FoundationOne Companion Diagnostic (F1CDx)

Foundation Medicine, Inc. · April 9, 2025

Reason for Recall

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.

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

4 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1747-2025

Status: ongoing

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