Lower riskMedical device recall · FDA · Published June 18, 2024
Foundation Medicine F1CDx Diagnostic Recall: Incorrect Negative Claim Reports
Foundation Medicine recalls F1CDx companion diagnostic reports with incorrect negative claims. Affected reports may have inaccurate results; contact for remedy.
Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
Take action
Contact the company
📍Recalling firmFoundation Medicine, Inc.150 2nd St · Cambridge, MA 02141-2115
“Foundation Medicine F1CDx Diagnostic Recall: Incorrect Negative Claim Reports.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54797-foundation-medicine-f1cdx-diagnostic-recall-incorrect-negative-claim-reports. Based on FDA recall #Z-1890-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1890-2025%22&limit=1).
The FDA announced on June 18, 2024, that Foundation Medicine, Inc. is recalling two units of the FoundationOne Companion Diagnostic (F1CDx) because customers received incorrect negative claims. The agency issued recall number Z-1890-2025 for the voluntary Class II action.
Two reports were sent to customers with an incorrect negative claim on the claims page. The device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
Context
GovInfoNow's records show Foundation Medicine, Inc. has had eight other recalls since October 31, 2018. Other recent recalls of similar products include Meridian Bioscience Revogene C. difficile Test Recall (December 5, 2025), HardyDisk AST Cefiderocol 30μg FDC30 (June 8, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026).
How to tell if you have this one
Check if your report has report numbers starting with ORD-XXXXX77-01 or ORD-XXXXX91-01. The device variant information is displayed correctly in the tumor profiling section.
Brand
Foundation Medicine
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Report Numbers
Look for report numbers starting with ORD-XXXXX77-01 or ORD-XXXXX91-01 on your F1CDx report.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of MI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 12 months 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-1890-2025 (June 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1890-2025 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.