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.
- Hazard
- reporting-error
- incorrect-diagnostic-claim
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22