Foundation Medicine, Inc.: Device Recall

Recall #Z-1747-2025 · 04/09/2025

Class II: Risk

Recall Details

Recall Number: Z-1747-2025
Classification: Class II
Product Type: Device
Recalling Firm: Foundation Medicine, Inc.
Status: Ongoing
Date Initiated: 04/09/2025
Location: Cambridge, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4 units

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.

Product Description

FoundationOne Companion Diagnostic (F1CDx)

Distribution Pattern

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

Other Recalls by Foundation Medicine, Inc.

Class II: Risk 06/18/2024

Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.

View all recalls by Foundation Medicine, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.