Foundation Medicine recalls FoundationOne Companion Diagnostic (F1CDx) due to incorrect negative claim on claims page. This may affect test accuracy but does not pose immediate safety risks.
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
Foundation Medicine is recalling its FoundationOne Companion Diagnostic (F1:CDx) because the claims page shows an incorrect negative claim. This could lead to inaccurate test results but does not involve physical safety risks.
The device shows an incorrect negative claim on the claims page, which could lead to inaccurate test results. This might cause misinterpretation of tumor profiling data. However, the test report's tumor profiling section displays the correct device variant information.
Patients using the FoundationOne Companion Diagnostic (F1CDx) for cancer testing may be affected. Those who have received the test report with the incorrect negative claim are most at risk.
Check if you have the FoundationOne Companion Diagnostic (F1CDx) with Report Number: ORD-XXXXX04-01. The recall note mentions redacted patient information to protect privacy.
Review the claims page for an incorrect negative claim. If present, contact Foundation Medicine for guidance.
No, this recall does not pose a safety risk. It affects test accuracy but not physical safety.
Check the claims page for an incorrect negative claim. If found, contact Foundation Medicine for guidance.
Look for Report Number: ORD-XXXXX04-01 on the claims page. The recall note mentions redacted patient information.
We’ve drafted a message you can send Foundation Medicine to request your refund or repair — edit it as you like.
Subject: Recall Z-1891-2025 — Foundation Medicine Foundation Medicine Hello, I own a Foundation Medicine that is covered by recall Z-1891-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
