Recall Z-0577-2026— Foundation Medicine, Inc.
Class II · Ongoing
Class II FDA medical device recall by Foundation Medicine, Inc., initiated 2022-11-08. FDA's recall record names no specific 510(k) clearance for this event. Product: FoundationOne CDx (F1CDx), RAL-0003 version 31.0. Reason: Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence..
- Recalling firm
- Foundation Medicine, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-08
- Firm location
- Cambridge, MA, United States
Product description
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Reason for recall
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Data sourced from openFDA. This site is unofficial and independent of the FDA.