Recall Z-0535-2020— Foundation Medicine, Inc.
Class II · Terminated
Class II FDA medical device recall by Foundation Medicine, Inc., initiated 2019-08-08, terminated 2021-07-19. FDA's recall record names no specific 510(k) clearance for this event. Product: FoundationOne CDx test report. Reason: Identified potential false positive MSI-H on the test reports provided to the physicians..
- Recalling firm
- Foundation Medicine, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-08
- Terminated
- 2021-07-19
- Firm location
- Cambridge, MA, United States
Product description
FoundationOne CDx test report
Reason for recall
Identified potential false positive MSI-H on the test reports provided to the physicians.
Data sourced from openFDA. This site is unofficial and independent of the FDA.