Foundation Medicine recalls F1LCDx version 6.0 due to missing companion diagnostic claims page. Affected units may not have the required claims page, potentially impacting test results. Contact for remedy details.
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 its FoundationOne Liquid CDx (F1LCDx) version 6.0 because some units were sent without the companion diagnostic claims page. This could affect test results if the claims page is missing, as it's required for proper use.
The companion diagnostic claims page is necessary for proper test interpretation. Without it, test results may be inaccurate, leading to potential misdiagnosis or incorrect treatment decisions.
Patients using FoundationOne Liquid CDx version 6.0 for cancer testing may be affected if their test kit lacks the companion claims page. Healthcare providers ordering the test are most at risk of incorrect results.
Check if your FoundationOne Liquid CDx (F1LCDx) version 6.0 test kit includes the companion diagnostic claims page. The test numbers listed in the recall include specific order codes for US and Japan.
Verify your test kit includes the companion diagnostic claims page as required by the manufacturer.
The recall is due to reports that some FoundationOne Liquid CDx (F1LCDx) version 6.0 units were sent without the companion diagnostic claims page.
Check if your FoundationOne Liquid CDx (F1LCDx) version 6.0 test kit includes the companion diagnostic claims page. The specific test numbers listed in the recall include order codes for US and Japan.
The recall does not specify a remedy, so contact Foundation Medicine directly for guidance on next steps.
We’ve drafted a message you can send Foundation Medicine to request your refund or repair — edit it as you like.
Subject: Recall Z-0578-2026 — Foundation Medicine Foundation Medicine Hello, I own a Foundation Medicine that is covered by recall Z-0578-2026 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.
