Lower risk Medical device recall · FDA · Published August 8, 2019

Foundation Medicine recalls FoundationOne CDx test reports with potential false positive

Foundation Medicine recalls specific FoundationOne CDx test reports that may show false positive MSI-H results, which could lead to incorrect cancer treatment decisions.

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

🇺🇸 FDA recall #Z-0535-2020Medical device Foundation Medicine ›

Lower-risk recall

Identified potential false positive MSI-H on the test reports provided to the physicians.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/67245-foundation-medicine-recalls-foundationone-cdx-test-reports-with-potential-false.

Source Summary by GovInfoNow · govinfonow.com/recall/67245-foundation-medicine-recalls-foundationone-cdx-test-reports-with-potential-false · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0535-2020

Cite this page

“Foundation Medicine recalls FoundationOne CDx test reports with potential false positive.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67245-foundation-medicine-recalls-foundationone-cdx-test-reports-with-potential-false. Based on FDA recall #Z-0535-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0535-2020%22&limit=1).

The FDA announced on August 8, 2019, that Foundation Medicine, Inc. voluntarily recalled eight FoundationOne CDx test reports due to potential false positive MSI-H results. The agency issued recall number Z-0535-2020 for the device classification II product.

How to tell if you have it

Brand: Foundation Medicine
Product: FoundationOne CDx test report
Lot numbers: QRF150009.01, QRF150228.01, QRF150108.01, QRF149795.01, QRF150117.01, QRF150247.01, QRF149634.01, QRF128938.01
Quantity: 8 reports
Distribution: MA, NC, IN, OH, GA

The hazard

According to the FDA, the recalled test reports contained identified potential false positive MSI-H results provided to physicians. The recall was classified as Class II.

Context

GovInfoNow's records show Foundation Medicine, Inc. has had eight other recalls on record since October 31, 2018. Recent recalls include the June 10, 2026, Hamilton Microlab STAR Liquid Handler PCT v2.0.0 Software Recall for spontaneous closures risk and the March 24, 2026, AutoLys STAR PCT software v1.3.0 recall for similar software closure issues. Other recent recalls of similar products include the July 6, 2026, Siemens Atellica CH Urine Albumin Recall for false results risk and the November 22, 2025, Menopause Test Cassette Recall for false results risk.

How to tell if you have this one

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.

Brand
Foundation Medicine
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Report Model Numbers
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.

Where it went and when

Where it was distributed

Distributed in 5 states.

FDA distribution: “MA, NC,IN, OH, GA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Georgia, Indiana, Massachusetts, North Carolina, Ohio.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

Aug 8, 2019Firm started the recall
Nov 22, 2019FDA classified it Class II
Dec 4, 2019Published in FDA’s Enforcement Report
Jul 19, 2021FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/67245-foundation-medicine-recalls-foundationone-cdx-test-reports-with-potential-false">Foundation Medicine recalls FoundationOne CDx test reports with potential false positive (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-0535-2020 (August 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0535-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.