BEUDAMED
    FDA Enforcement Class II Ongoing

    Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

    Recall: Z-1927-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1927-2026
    Event ID
    98625
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Foundation Medicine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 29, 2026
    Initiation Date
    March 20, 2026
    Classification Date
    April 22, 2026
    Address
    150 2nd St, N/A, Cambridge, MA, 02141-2115, United States

    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

    Code Info

    Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.

    Distribution

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

    Quantity

    163 units