Foundation Medicine recalls F1CDx version 31.0 due to missing companion diagnostic claims page. Affected units may not function properly without the required claims page.
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Foundation Medicine is recalling F1CDx version 31.0 because some units were sent without the companion diagnostic claims page. This could prevent proper use of the test without the required claims page.
The test requires a companion diagnostic claims page to function correctly. Without this page, the test may not work as intended for cancer diagnosis.
Patients using FoundationOne CDx (F1CDx) version 31.0 for cancer testing may be affected. Those who received the test without the companion diagnostic claims page are most at risk.
Check for the product name 'FoundationOne CDx (F1CDx)' with version number RAL-0003 v31.0. The test was distributed with specific order numbers in the US, Singapore, and Japan.
Ensure you have the companion diagnostic claims page included with your test kit.
The recall is because some units were sent without the companion diagnostic claims page, which is required for proper function.
Check for the product name 'FoundationOne CDx (F1CDx)' with version RAL-0003 v31.0 and specific order numbers listed in the recall notice.
Ensure you have the companion diagnostic claims page included with your test kit. If missing, contact Foundation Medicine for assistance.
We’ve drafted a message you can send Foundation Medicine to request your refund or repair — edit it as you like.
Subject: Recall Z-0577-2026 — Foundation Medicine Foundation Medicine Hello, I own a Foundation Medicine that is covered by recall Z-0577-2026 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.
