Foundation Medicine, Inc. FoundationOne Companion Diagnostic (F1CDx) Recall
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 Number: ORD-XXXXX04-01, Note: The above characters have been redacted to minimize patient information disclosure.
Products Sold
Report Number: ORD-XXXXX04-01; Note: The above characters have been redacted to minimize patient information disclosure.
Foundation Medicine, Inc. is recalling FoundationOne Companion Diagnostic (F1CDx) due to An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section o. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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