BEUDAMED
    FDA Enforcement Class III Ongoing

    Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

    Recall: Z-1358-2023 · Reported April 19, 2023

    Enforcement

    Recall Number
    Z-1358-2023
    Event ID
    91863
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AGILENT TECHNOLOGIES INC./US
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2023
    Initiation Date
    February 17, 2023
    Classification Date
    April 11, 2023
    Address
    550 Kirkland Way, Suite, N/A, Kirkland, WA, 98033, United States

    Description

    Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

    Reason

    Distributed sample collection kit with an unapproved instruction for use.

    Code Info

    Model/Part Number: 50032 UDI Code: N/A, single site PMA Lot Numbers: 23-0139 23-0140 23-0142 23-0143 23-0159

    Distribution

    U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None

    Quantity

    560 kits