Reported Jun 11, 2025 · Ongoing
FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Foundation Medicine, Inc. · 150 2nd St · Cambridge, MA · 02141-2115
Is this the product you have?
- FoundationOne Companion Diagnostic (F1CDx)
- Lot codes and dates
- Report Numbers
ORD-XXXXX77-01ORD-XXXXX91-01
- NoteThe above characters have been redacted to minimize patient information disclosure
- Report Numbers
- Amount recalled
- 2 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- MI
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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