Lower riskMedical device recall · FDA · Published February 15, 2023
FoundationOne Companion Diagnostic Recall: Incorrect Negative Claim on Claims Page
Foundation Medicine recalls FoundationOne Companion Diagnostic (F1CDx) due to incorrect negative claim on claims page. This may affect test accuracy but does not pose immediate safety risks.
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
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Contact the company
📍Recalling firmFoundation Medicine, Inc.150 2nd St · Cambridge, MA 02141-2115
“FoundationOne Companion Diagnostic Recall: Incorrect Negative Claim on Claims Page.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/58886-foundationone-companion-diagnostic-recall-incorrect-negative-claim-on-claims-page. Based on FDA recall #Z-1891-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1891-2025%22&limit=1).
The FDA announced on Feb. 15, 2023, that Foundation Medicine, Inc. is recalling the FoundationOne Companion Diagnostic (F1CDx) due to an incorrect negative claim on the claims page. This Class II recall involves one unit distributed nationwide in Wisconsin.
According to the FDA, an incorrect negative claim was identified on the claims page of the device. The device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
Context
GovInfoNow's records show Foundation Medicine, Inc. has had eight other recalls since Oct. 31, 2018. Recent brand recalls include a June 10, 2026, recall of Hamilton Microlab STAR Liquid Handler PCT v2.0.0 Software for spontaneous closures risk and a March 24, 2026, recall of AutoLys STAR PCT software v1.3.0 for the same hazard. Other recent recalls of similar products include Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025), DFI One Step P Diagnostic Test Recall (April 2, 2026), and HardyDisk AST Cefiderocol 30μg FDC30 recall (June 8, 2026).
How to tell if you have this one
Check if you have the FoundationOne Companion Diagnostic (F1CDx) with Report Number: ORD-XXXXX04-01. The recall note mentions redacted patient information to protect privacy.
Brand
Foundation Medicine
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Your Report
Review the claims page for an incorrect negative claim. If present, contact Foundation Medicine for guidance.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1891-2025 (February 15, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1891-2025 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.