FoundationOne Companion Diagnostic (F1CDx)
Reported: May 21, 2025 Initiated: April 9, 2025 #Z-1747-2025
Product Description
FoundationOne Companion Diagnostic (F1CDx)
Reason for Recall
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.
Details
- Recalling Firm
- Foundation Medicine, Inc.
- Units Affected
- 4 units
- Distribution
- Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
FoundationOne Companion Diagnostic (F1CDx). Recalled by Foundation Medicine, Inc.. Units affected: 4 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 21, 2025. Severity: Moderate. Recall number: Z-1747-2025.
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