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 NumberORD-XXXXX04-01
- NoteThe above characters have been redacted to minimize patient information disclosure
- Amount recalled
- 1 unit
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
- WI
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Foundation Medicine, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.