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Open, Classified

FoundationOne Companion Diagnostic (F1CDx)

FDA Recall Z-1890-2025 · Posted 2025-05-30

Recalling FirmFoundation Medicine, Inc.
Recall StatusOpen, Classified
Product CodePQP
Date Initiated2024-06-18
Product Quantity2 units

Reason for Recall

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.

Firm Action

On June 18, 2024, amended reports were sent to customers. It was to alert customers to an amended report that was recently released on 6/18/24. The new report replaces the report of 2/11/24. Additional contact was made on June 20, 2024 to communicate the error and provide the updated report to the customer.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution in the state of MI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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