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Open, Classified

FoundationOne Companion Diagnostic (F1CDx)

FDA Recall Z-1891-2025 · Posted 2025-05-30

Recalling FirmFoundation Medicine, Inc.
Recall StatusOpen, Classified
Product CodePQP
Date Initiated2023-02-15
Product Quantity1 unit

Reason for Recall

An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.

Firm Action

On February 15, 2023, the physician was alerted of the amended report within the physician's portal. Physician was informed original report included an incorrect negative CDx claim on the claims page; the CDx variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. It is requested that any impact to patient care be forwarded to Foundation Medicine.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution in the state of WI.

Official Source

View FDA Recall →

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

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