Foundation Medicine, Inc. is recalling two units of the FoundationOne Companion Diagnostic (F1CDx) test because two patient reports were issued with incorrect information. Specifically, the reports contained an incorrect negative claim on the results page, even though the specific genetic variant details were correctly listed in a different section of the same report. While no injuries or incidents have been reported, this error could potentially lead to confusion regarding treatment options based on the diagnostic results.
Patients and healthcare providers may rely on the incorrect negative claim to make treatment decisions, potentially leading to inappropriate medical care. No injuries have been reported to date.
Report numbers have been partially redacted to protect patient privacy.
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.
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Sources: FDA iRES · Raw API Response
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