BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated March 24, 2026

    Recall

    Recall Number
    Z-1937-2026
    Event Number
    98640
    Firm
    Foundation Medicine, Inc.
    FEI Number
    3010679023
    Product Code
    PQP
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    March 24, 2026
    Posted
    April 23, 2026
    Address
    150 2nd St, Cambridge, MA, 02141-2115

    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.

    Action

    Foundation Medicine, Inc. (FMI) notified consignees of the recall on 03/24/2026 via emailed URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letter. Consignees were instructed to complete and return the provided business reply form, review impacted equipment and verify that the PCT V1.3.1 version of the software has been installed, and if the PCT V1.3.1 has not been installed upon the equipment listed above, to indicate as such on the business reply form below. FMI will follow up to assist with installation. Consignees were also instructed to forward the notification to applicable personnel and if there is any impact that requires the notice to be forwarded to another facility, contact that facility and provide them with the notification letter.

    Distribution

    US distribution to North Carolina and Massachusetts.

    Quantity

    10 units