FoundationOne Companion Diagnostic Reports Contain Incorrect Claims
Two FoundationOne Companion Diagnostic reports contained incorrect negative claims on the claims page, though tumor profiling data displayed correctly. No patient harm reported.
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: Class II recall involving labeling errors on test reports. No hospitalization or patient injury reports. Actual tumor profiling data displayed correctly, mitigating risk.
Plain-English summary
Foundation Medicine issued two customer reports for the FoundationOne Companion Diagnostic (F1CDx) that contained incorrect negative claims on the claims page. The device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
This Class II recall affects the incorrect claims display only. The tumor profiling section of both reports contained correct device variant information, limiting potential patient impact from the labeling error.
Customers in possession of these reports should consult the tumor profiling section for accurate device variant information. Those with questions about the accuracy of their results should contact Foundation Medicine, Inc.
The recalled product
- Product
- FoundationOne Companion Diagnostic (F1CDx)
- Manufacturer
- Foundation Medicine, Inc.
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Report Numbers: ORD-XXXXX77-01
Distribution
Distributed nationwide across the United States.
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