Recall Z-1927-2026— Foundation Medicine, Inc.
Class II · Ongoing
Class II FDA medical device recall by Foundation Medicine, Inc., initiated 2026-03-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx). Reason: Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants.
- Recalling firm
- Foundation Medicine, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-20
- Firm location
- Cambridge, MA, United States
Product description
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Reason for recall
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Data sourced from openFDA. This site is unofficial and independent of the FDA.