Foundation Medicine recalls FoundationOne CDx Test Results for up to 800 physician reports that may have shown incorrect results for a single analyte. Affected reports can be identified by specific specimen numbers.
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
Foundation Medicine is recalling FoundationOne CDx Test Results for up to 800 physician reports that may have shown incorrect results for a single analyte. This could lead to inaccurate medical decisions if the test results are used without verification.
The recall indicates that for up to 800 physician reports, a single analyte in the test result may have been incorrectly reported. This could lead to inaccurate medical decisions if the test results are used without verification, but the risk is limited to one specific analyte.
Physicians who received FoundationOne CDx Test Results with specimen numbers listed in the recall are affected. The risk is low as the issue only affects a single analyte in a test result, not the entire test.
Check if your FoundationOne CDx Test Results report has a specimen number listed in the provided list of numbers (e.g., QRF038638, QRF039891, etc.).
Check if your FoundationOne CDx Test Results report has a specimen number listed in the provided list of numbers.
Foundation Medicine recalls FoundationOne CDx Test Results for up to 800 physician reports that may have shown incorrect results for a single analyte.
Check if your FoundationOne CDx Test Results report has a specimen number listed in the provided list of numbers (e.g., QRF038638, QRF039891, etc.).
Verify your report's specimen number against the list provided in the recall. If it matches, contact Foundation Medicine for further instructions.
We’ve drafted a message you can send Foundation Medicine to request your refund or repair — edit it as you like.
Subject: Recall Z-0649-2019 — Foundation Medicine Foundation Medicine Hello, I own a Foundation Medicine that is covered by recall Z-0649-2019 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.
