medical Class II Updated 2025-05-21

Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)

Recalled Product

FoundationOne Companion Diagnostic (F1CDx)

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 Note: The above characters have been redacted to minimize patient information disclosure.
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