Z-1927-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2026
- Initiation Date
- March 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 163 units
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
Distribution Pattern
US Nationwide distribution in the states of Massachusetts and North Carolina.
Code Information
Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.