Z-1891-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2025
- Initiation Date
- February 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
FoundationOne Companion Diagnostic (F1CDx)
Reason for Recall
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
Distribution Pattern
US Nationwide distribution in the state of WI.
Code Information
Report Number: ORD-XXXXX04-01; Note: The above characters have been redacted to minimize patient information disclosure.