Foundation Medicine recalls F1CDx companion diagnostic reports with incorrect negative claims. Affected reports may have inaccurate results; contact for remedy.
Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
Foundation Medicine is recalling F1:CDx companion diagnostic reports that show incorrect negative claims. This could lead to inaccurate cancer test results, which might affect treatment decisions.
The reports contain two incorrect negative claims, meaning they might show a test result as negative when it's actually positive. This could lead to incorrect cancer treatment decisions if the test is used for diagnosis.
Patients using Foundation Medicine's F1CDx companion diagnostic reports for cancer testing. Those with reports showing incorrect negative claims are most at risk.
Check if your report has report numbers starting with ORD-XXXXX77-01 or ORD-XXXXX91-01. The device variant information is displayed correctly in the tumor profiling section.
Look for report numbers starting with ORD-XXXXX77-01 or ORD-XXXXX91-01 on your F1CDx report.
The reports show incorrect negative claims, which could lead to inaccurate cancer test results and affect treatment decisions.
Check for report numbers starting with ORD-XXXXX77-01 or ORD-XXXXX91-01 on your F1CDx report.
The recall record does not specify a remedy, so contact Foundation Medicine directly for guidance.
We’ve drafted a message you can send Foundation Medicine to request your refund or repair — edit it as you like.
Subject: Recall Z-1890-2025 — Foundation Medicine Foundation Medicine Hello, I own a Foundation Medicine that is covered by recall Z-1890-2025 from Foundation Medicine. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
