Foundation Medicine, Inc. recalls Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
- Recall date
- March 20, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1927-2026
- FDA classification
- Class II
- Brand / firm
- Foundation Medicine, Inc.
- Sold / distributed
- US Nationwide distribution in the states of Massachusetts and North Carolina.
Why it was recalled
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
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