UnratedMedical device recall · FDA · Published April 9, 2025
Foundation Medicine recalls F1CDx companion diagnostic with variant reporting issues
Foundation Medicine recalls F1CDx companion diagnostic due to four reports of clinically relevant variants requiring amendment, one with incorrect negative claim. No remedy specified in recall notice.
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
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Contact the company
📍Recalling firmFoundation Medicine, Inc.150 2nd St · Cambridge, MA 02141-2115
“Foundation Medicine recalls F1CDx companion diagnostic with variant reporting issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52478-foundation-medicine-recalls-f1cdx-companion-diagnostic-with-variant-reporting-issues. Based on FDA recall #Z-1747-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1747-2025%22&limit=1).
Foundation Medicine, Inc. recalled FoundationOne Companion Diagnostic (F1CDx) kits on April 9, 2025, according to the Food and Drug Administration. The recall addresses four reports of customers receiving clinically relevant variants requiring amendment, including one with an incorrect negative CDx claim.
How to tell if you have it
Foundation Medicine
FoundationOne Companion Diagnostic (F1CDx)
ORD-XXXXX28-01
ORD-XXXXX98-01
ORD-XXXXX29-01
ORD-XXXXX99-01
The hazard
The FDA said four total reports were sent to customers with clinically relevant variants requiring amendment. One report involved an incorrect negative CDx claim, while the remaining three tumor profiling result changes did not impact CDx indications.
Context
GovInfoNow's records show Foundation Medicine, Inc. has had eight other recalls on record since October 31, 2018. Recent brand recalls include a June 10, 2026 software recall for the Hamilton Microlab STAR Liquid Handler PCT v2.0.0 and a March 24, 2026 recall for AutoLys STAR PCT software v1.3.0 due to spontaneous closures risks. Other recent recalls of similar products include the HardyDisk AST Cefiderocol 30μg FDC30 (June 8, 2026), Meridian Bioscience Revogene C. difficile Test (December 5, 2025), and DFI One Step P Diagnostic Test (April 2, 2026).
How to tell if you have this one
Check if you have the FoundationOne Companion Diagnostic (F1CDx) product with the model numbers shown in the recall notice. The product was sold with specific order numbers that have been redacted for privacy.
Brand
Foundation Medicine
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Review the product model and order numbers to confirm if you have the recalled FoundationOne Companion Diagnostic (F1CDx).
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Georgia, New York.
Recall timeline
FDA published this recall 42 days 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-1747-2025 (April 9, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1747-2025 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.