Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

FDA device recall Z-1927-2026 · posted 2026-04-22 · Open, Classified

Recall details

Recalling firm

Foundation Medicine, Inc.

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PQP

Quantity affected

163 units

Distribution

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

Date initiated

2026-03-20

Date posted

2026-04-22

Location

Cambridge, MA