Foundation Medicine recalls F1CDx companion diagnostic due to four reports of clinically relevant variants requiring amendment, one with incorrect negative claim. No remedy specified in recall notice.
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
Foundation Medicine is recalling their F1CDx companion diagnostic product because four reports showed clinically relevant genetic variants that needed correction. One report had an incorrect negative claim, but the other three did not affect the diagnostic results.
The recall involves four reports of clinically relevant genetic variants that required amendment. One report had an incorrect negative claim, meaning the test might have incorrectly indicated no cancer variants when variants were present. The other three reports did not change the diagnostic indications.
Patients using the FoundationOne Companion Diagnostic (F1CDx) for cancer testing may be affected. Those with the specific variant reports mentioned in the recall are at higher risk.
Check if you have the FoundationOne Companion Diagnostic (F1CDx) product with the model numbers shown in the recall notice. The product was sold with specific order numbers that have been redacted for privacy.
Review the product model and order numbers to confirm if you have the recalled FoundationOne Companion Diagnostic (F1CDx).
The recall is due to four reports of clinically relevant genetic variants requiring amendment, one with an incorrect negative claim.
The remaining three reports did not impact the diagnostic indications, so most results remain valid.
The recall notice does not specify a remedy, so no action is required beyond checking if you have the product.
We’ve drafted a message you can send Foundation Medicine to request your refund or repair — edit it as you like.
Subject: Recall Z-1747-2025 — Foundation Medicine Foundation Medicine Hello, I own a Foundation Medicine that is covered by recall Z-1747-2025 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.
