FoundationOne Companion Diagnostic Recalled for Incorrect Negative Claim Display
Foundation Medicine is recalling the FoundationOne Companion Diagnostic (F1CDx) due to an incorrect negative claim displayed on the claims page. The actual test results in the approved report were correct.
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 a labeling error (incorrect claim on the claims page). No reported illnesses, injuries, or patient harm. The actual diagnostic information in the approved test report was correct, meeting the criteria for minor labeling errors.
Plain-English summary
Foundation Medicine, Inc. is recalling the FoundationOne Companion Diagnostic (F1CDx), a companion diagnostic test device used for tumor profiling and treatment decision support.
An incorrect negative claim was identified on the device's claims page. While the device variant information was correctly displayed in the tumor profiling section of the FDA-approved test report, the error in the claims page presentation could lead to misinterpretation of the device's capabilities.
The F1CDx has been distributed nationwide, including in Wisconsin. This is a Class II recall.
If you have received F1CDx test results, review them directly from the approved test report and consult your healthcare provider if you have questions about your results or the test's capabilities.
The recalled product
- Product
- FoundationOne Companion Diagnostic (F1CDx)
- Manufacturer
- Foundation Medicine, Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- incorrect-claim
- labeling-error
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 Number: ORD-XXXXX04-01
Distribution
Distributed nationwide across the United States.
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