FDA Medical devices recall ·
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) recall
- Recall number
- Z-1927-2026
- Date
- (initiated March 20, 2026)
- Company / brand
- Foundation Medicine, Inc.
150 2nd St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 163 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Why was it recalled?
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
Distribution
US Nationwide distribution in the states of Massachusetts and North Carolina.
States: Massachusetts North Carolina
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1927-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.