Recall Z-1891-2025— Foundation Medicine, Inc.
Class II · Ongoing
Class II FDA medical device recall by Foundation Medicine, Inc., initiated 2023-02-15. FDA's recall record names no specific 510(k) clearance for this event. Product: FoundationOne Companion Diagnostic (F1CDx). Reason: 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..
- Recalling firm
- Foundation Medicine, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-15
- Firm location
- Cambridge, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.