Class II

Medical Device Recall: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

Foundation Medicine, Inc. · March 20, 2026

Reason for Recall

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

Distribution

US Nationwide distribution in the states of Massachusetts and North Carolina.

States Affected

NATIONWIDE

Quantity Affected

163 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1927-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.