FoundationOne CDx (Foundation Medicine) – Report Discrepancy (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FoundationOne Companion Diagnostic (F1CDx)
Brand
Foundation Medicine, Inc.
Lot Codes / Batch Numbers
Report Numbers: ORD-XXXXX77-01
Products Sold
Report Numbers: ORD-XXXXX77-01, ORD-XXXXX91-01. Note: The above characters have been redacted to minimize patient information disclosure.
Foundation Medicine, Inc. is recalling FoundationOne Companion Diagnostic (F1CDx) due to Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026