The Recall Desk
ModerateFDA (Devices)·Z-1747-2025·Announced 2025-05-21

FoundationOne Companion Diagnostic reports clinically relevant variants requiring amendment

Foundation Medicine is recalling four FoundationOne Companion Diagnostic (F1CDx) test reports sent to customers that contained clinically relevant variants requiring amendment, including one with an incorrect negative companion diagnostic claim.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving test report errors that could affect clinical decision-making. The source does not report any confirmed illnesses or injuries, and most reports (3 of 4) did not impact diagnostic indications, making this a moderate-level precautionary recall.

Plain-English summary

Foundation Medicine, Inc. is recalling four (4) FoundationOne Companion Diagnostic (F1CDx) test reports that were sent to customers. The reports contained clinically relevant variants that require amendment.

Of the four reports, one contained an incorrect negative companion diagnostic claim. The remaining three reports contained tumor profiling result changes but did not impact companion diagnostic indications.

Affected customers who received these reports should contact Foundation Medicine, Inc. for corrected results and guidance on the appropriate clinical actions based on the amended findings.

The recalled product

Product
FoundationOne Companion Diagnostic (F1CDx)
Manufacturer
Foundation Medicine, Inc.
Category
Medical Device — Companion Diagnostic / In Vitro Diagnostic
Hazard
Affected units
4

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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