Foundation Medicine, Inc. is recalling one unit of the FoundationOne Companion Diagnostic (F1CDx) test report due to an incorrect negative claim found on the test's claims page. While the tumor profiling section of the FDA-approved report correctly displayed the device variant information, the conflicting negative claim on the claims page provided inaccurate results for that specific patient. No injuries or incidents have been reported in connection with this error.
Incorrect test results can cause healthcare providers to make inappropriate treatment decisions, as the diagnostic data does not accurately reflect the patient's genetic profile. This poses a risk of improper medical management for the affected individual.
Quantity: 1 unit. The report number has been partially redacted in the source data to minimize patient information disclosure.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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