Foundation Medicine recalls specific FoundationOne CDx test reports that may show false positive MSI-H results, which could lead to incorrect cancer treatment decisions.
Identified potential false positive MSI-H on the test reports provided to the physicians.
Foundation Medicine is recalling certain FoundationOne CDx test reports that might show false positive results for MSI-H. This could lead to incorrect cancer treatment decisions if doctors rely on these reports.
The test reports could show false positive results for MSI-H, a biomarker used in cancer treatment. This might lead doctors to choose incorrect treatments for patients. The false positives could cause unnecessary treatment or delays in proper care.
Physicians and labs using the recalled test reports may be affected. Those who have received the specific model/lot numbers listed are most at risk.
Check if your test report has a model/lot number starting with QRF150009.01, QRF150228.0: QRF150108.01, QRF149795.01, QRF150117.01, QRF150247.01, QRF149634.01, or QRF128938.01.
Verify your test report's model/lot number against the listed numbers: QRF150009.01, QRF150228.01, QRF150108.01, QRF149795.01, QRF150117.01, QRF150247.01, QRF149634.01, QRF128938.01.
The test reports may show false positive results for MSI-H, which could lead to incorrect cancer treatment decisions.
Test reports with model/lot numbers starting with QRF150009.01, QRF150228.01, QRF150108.01, QRF149795.01, QRF150117.01, QRF150247.01, QRF149634.01, or QRF128938.01.
Check your report's model/lot number against the listed numbers. If it matches, contact Foundation Medicine 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-0535-2020 — Foundation Medicine Foundation Medicine Hello, I own a Foundation Medicine that is covered by recall Z-0535-2020 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.
