BEUDAMED
    FDA Enforcement Class II Ongoing

    Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.

    Recall: Z-1937-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1937-2026
    Event ID
    98640
    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 24, 2026
    Classification Date
    April 23, 2026
    Address
    150 2nd St, N/A, Cambridge, MA, 02141-2115, United States

    Description

    Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.

    Reason

    Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.

    Code Info

    Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)

    Distribution

    US distribution to North Carolina and Massachusetts.

    Quantity

    10 units