BEUDAMED
    FDA Enforcement Class II Ongoing

    Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

    Recall: Z-0428-2026 · Reported November 12, 2025

    Enforcement

    Recall Number
    Z-0428-2026
    Event ID
    97730
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 12, 2025
    Initiation Date
    October 1, 2025
    Classification Date
    November 4, 2025
    Address
    1000 Lake Hazeltine Dr, N/A, Chaska, MN, 55318-1037, United States

    Description

    Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

    Reason

    An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.

    Code Info

    A71460, UDI/DI 15099590369224, Serial Numbers: 902515, 902529, 902528, 902534, 902526, 902527, 902523, 902522, 902524, 902505, 902578, 902579, 902545, 902530, 902531, 902581, 902504, 902514, 902525, 902535, 902566, 902516, 902518, 902532, 902555, 902558, 902564, 902519, 902521, 902559, 902511, 902549, 902554, 902547, 902582, 902583; A30260, UDI/DI 15099590341602, Serial Numbers: 902536, 902541, 902517, 902563, 902565, 902557, 902513, 902507, 902543, 902560, 902562, 902506, 902508, 902574, 902533, 902572, 902540, 902569, 902568, 902577, 902510, 902580, 902567, 902573, 902570, 902571, 902538, 902553, 902552, 902512, 902539, 902561, 902575, 902544, 902542, 902556, 902537, 902509, 902520, 902546, 902548, 902551, 902550, 902576.

    Distribution

    Worldwide

    Quantity

    80 units