Z-1890-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2025
- Initiation Date
- June 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
FoundationOne Companion Diagnostic (F1CDx)
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 Pattern
US Nationwide distribution in the state of MI.
Code Information
Report Numbers: ORD-XXXXX77-01, ORD-XXXXX91-01. Note: The above characters have been redacted to minimize patient information disclosure.