Foundation Medicine, Inc. has recalled 4 units of the FoundationOne Companion Diagnostic (F1CDx) due to errors in patient test reports. Of the four reports issued, one contained an incorrect negative result for a companion diagnostic claim, while the other three required amendments for tumor profiling variants that did not affect diagnostic indications. No injuries have been reported, and the firm has contacted affected customers via letter to provide amended reports.
Incorrect test results could lead healthcare providers to make inappropriate treatment decisions or miss potential therapeutic options for patients. One specific report wrongly indicated a negative result for a diagnostic marker used to determine treatment eligibility.
The characters in the order codes have been redacted by the manufacturer 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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.