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Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
Recalled June 11, 2025 · FDA recall Z-1891-2025 · Foundation Medicine
Hazard
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. · FDA Class II
Units
1 unit
Sold at
US Nationwide distribution in the state of WI.
Description
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.
Product
FoundationOne Companion Diagnostic (F1CDx)
Manufacturer(s)
Foundation Medicine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →