Device product
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Z-1927-2026
Product summary
- Event
- Event 98625
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 163 units
- Official record key
device-enforcement:Z-1927-2026
Official wording
Reason: Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Code information: Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
Distribution pattern: US Nationwide distribution in the states of Massachusetts and North Carolina.
Derived failure modes
-
Unknown
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants