FDA recall Z-1927-2026

Foundation Medicine, Inc. · Class II · device

Product

Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

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.

Key facts

Status
Ongoing
Initiation date
2026-03-20
Report date
2026-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1927-2026