FoundationOne Companion Diagnostic (F1CDx)
FDA device recall Z-1890-2025 · posted 2025-05-30 · Open, Classified
Recall details
- Recalling firm
- Foundation Medicine, Inc.
- 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.
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- PQP
- Quantity affected
- 2 units
- Distribution
- US Nationwide distribution in the state of MI.
- Date initiated
- 2024-06-18
- Date posted
- 2025-05-30
- Location
- Cambridge, MA
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