Foundation Medicine, Inc. recalls Sequencing Agent SEQ0067
- Recalling company
- Foundation Medicine, Inc.
- 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
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 20, 2026
- Reported
- Apr 29, 2026
- Distribution
- US Nationwide distribution in the states of Massachusetts and North Carolina.
- Status
- Ongoing
- Quantity
- 163 units
- Lot / codes
- Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
- Company location
- Cambridge, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1927-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1927-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.