Official recall notice
FDA DeviceClass IINotable
FDA Recall: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
- Recall date
- 2026-04-29
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Recommended action
What to do
163 units
Product description
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants