FDAHealthMarch 20, 2026
Foundation Medicine, Inc. — Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
⚠️ Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 20, 2026
US Nationwide distribution in the states of Massachusetts and North Carolina.
What's affected?
- Product
- Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
- Lot code
- 24346
Additional details
Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 163 units.
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