Foundation Medicine, Inc. recalls Sequencing Agent SEQ0067

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

Foundation Medicine notified consignees via emailed letter on about 03/20/2026. Consignees were instructed to review, complete, sign and return the provided business reply form and review inventory and identify affected units, quarantine those units, and return to the FMI Boston Warehouse quarantine location via standard laboratory transfer practices. Consignees were also instructed to forward the notification to anyone within the facility that should be informed and if there is any impact that requires this notice to be forwarded to another facility, including facilities where units of inventory may have been transferred, contact that facility and provide them with this letter. Consignees were asked to retain the letter with laboratory records made aware that Foundation Medicine will work with the supplier of these components to replace impacted units.

• FDA enforcement recordOfficial FDA database entry for Z-1927-2026
• FDA device classification · PQPOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Foundation Medicine, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.