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FDAMarch 20, 2026device

Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants

What to do

FDA enforcement status: Ongoing

Brands named

foundation medicinefoundation

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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