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
- February 15, 2023
- Posted
- May 30, 2025
- Recall Number
- Z-1891-2025
- Quantity
- 1 unit
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
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
US Nationwide distribution in the state of WI.
Lot / Code Info
Report Number: ORD-XXXXX04-01; Note: The above characters have been redacted to minimize patient information disclosure.
Root Cause
Software design
Action Taken
On February 15, 2023, the physician was alerted of the amended report within the physician's portal. Physician was informed original report included an incorrect negative CDx claim on the claims page; the CDx variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. It is requested that any impact to patient care be forwarded to Foundation Medicine.