Lower risk Medical device recall · FDA · Published October 31, 2018

Foundation Medicine recalls FoundationOne CDx Test Results due to potential incorrect test

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0649-2019Medical device Foundation Medicine ›

Lower-risk recall

An incorrect test result for a single analyte may have been reported for up to 800 physician reports

Take action

Contact the company

Recalling firmFoundation Medicine, Inc.150 2nd St · Cambridge, MA 02141-2115

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/69536-foundation-medicine-recalls-foundationone-cdx-test-results-due-to-potential.

Source Summary by GovInfoNow · govinfonow.com/recall/69536-foundation-medicine-recalls-foundationone-cdx-test-results-due-to-potential · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0649-2019

Cite this page

“Foundation Medicine recalls FoundationOne CDx Test Results due to potential incorrect test.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/69536-foundation-medicine-recalls-foundationone-cdx-test-results-due-to-potential. Based on FDA recall #Z-0649-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0649-2019%22&limit=1).

The FDA announced on 2018-10-31 that Foundation Medicine, Inc. is recalling FoundationOne CDx Test Results for up to 800 physician reports due to the risk of incorrect test results for a single analyte. According to the FDA, the recall affects specimens distributed nationwide.

How to tell if you have it

Brand: Foundation Medicine
Product: FoundationOne CDx Test Results
Specimen Numbers: QRF038638 through QRF056620 (see full list in record)
Units affected: Up to 800 physician reports

The hazard

An incorrect test result for a single analyte may have been reported. The recall covers up to 800 physician reports.

Context

GovInfoNow's records show Foundation Medicine, Inc. has had 8 other recalls since 2019-08-08. Recent brand recalls include a 2026-06-10 recall of Hamilton Microlab STAR Liquid Handler PCT v2.0.0 Software for spontaneous closures risk and a 2026-03-24 recall of AutoLys STAR PCT software v1.3.0 for the same hazard. Other recent recalls of similar products include Siemens Atellica CH Urine Albumin Recall (2026-07-06), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (2026-07-13), and DFI One Step P Diagnostic Test Recall (2026-04-02).

How to tell if you have this one

Check if your FoundationOne CDx Test Results report has a specimen number listed in the provided list of numbers (e.g., QRF038638, QRF039891, etc.).

Brand
Foundation Medicine
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Verify Your Report
Check if your FoundationOne CDx Test Results report has a specimen number listed in the provided list of numbers.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

Oct 31, 2018Firm started the recall
Dec 20, 2018FDA classified it Class II
Dec 26, 2018Published in FDA’s Enforcement Report
Apr 17, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Foundation Medicine recalls

Link to this recall

<a href="https://govinfonow.com/recall/69536-foundation-medicine-recalls-foundationone-cdx-test-results-due-to-potential">Foundation Medicine recalls FoundationOne CDx Test Results due to potential incorrect test (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0649-2019 (October 31, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0649-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.