FDAFDA · Food and drugs·Recall number Z-1747-2025
FoundationOne Companion Diagnostic (F1CDx)
Published May 21, 2025 · Recall initiated: April 9, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Foundation Medicine, Inc.
- Distributor
- Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.
- Lot
- ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 Note: The above characters have been redacted to minimize patient information disclosure.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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