BEUDAMED
    FDA Recall Open, Classified

    Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

    Recall: Z-1927-2026 · Initiated March 20, 2026

    Recall

    Recall Number
    Z-1927-2026
    Event Number
    98625
    Firm
    Foundation Medicine, Inc.
    FEI Number
    3010679023
    Product Code
    PQP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 20, 2026
    Posted
    April 22, 2026
    Address
    150 2nd St, Cambridge, MA, 02141-2115

    Description

    Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

    Reason

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

    Action

    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.

    Distribution

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

    Quantity

    163 units