Reported May 21, 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
- ORD-XXXXX28-01 ORD-XXXXX98-01
- ORD-XXXXX29-01 ORD-XXXXX99-01 NoteThe above characters have been redacted to minimize patient information disclosure
- Amount recalled
- 4 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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