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Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
Recalled May 21, 2025 · FDA recall Z-1747-2025 · Foundation Medicine
Hazard
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. · FDA Class II
Units
4 units
Sold at
Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.
Description
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
FoundationOne Companion Diagnostic (F1CDx)
Manufacturer(s)
Foundation Medicine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →