Recall Z-1747-2025— Foundation Medicine, Inc.

Name: FDA recall Z-1747-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-09

Class II · Ongoing

Class II FDA medical device recall by Foundation Medicine, Inc., initiated 2025-04-09. FDA's recall record names no specific 510(k) clearance for this event. Product: FoundationOne Companion Diagnostic (F1CDx). Reason: 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..

Recalling firm: Foundation Medicine, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-04-09
Firm location: Cambridge, MA, United States

Product description

FoundationOne Companion Diagnostic (F1CDx)

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.