FoundationOne Companion Diagnostic (F1CDx)
This recall is currently active, issued May 30, 2025. It was issued by Foundation Medicine, Inc..
- Company
- Foundation Medicine, Inc.
- Recall Initiated
- June 18, 2024
- Posted
- May 30, 2025
- Recall Number
- Z-1890-2025
- Quantity
- 2 units
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of MI.
Lot / Code Info
Report Numbers: ORD-XXXXX77-01, ORD-XXXXX91-01. Note: The above characters have been redacted to minimize patient information disclosure.
Root Cause
Software design
Action Taken
On June 18, 2024, amended reports were sent to customers. It was to alert customers to an amended report that was recently released on 6/18/24. The new report replaces the report of 2/11/24. Additional contact was made on June 20, 2024 to communicate the error and provide the updated report to the customer.