BEUDAMED
    FDA Enforcement Class II Ongoing

    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

    Recall: Z-0286-2025 · Reported November 13, 2024

    Enforcement

    Recall Number
    Z-0286-2025
    Event ID
    95504
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2024
    Initiation Date
    September 24, 2024
    Classification Date
    November 1, 2024
    Address
    2 Edgewater Dr, N/A, Norwood, MA, 02062-4637, United States

    Description

    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

    Reason

    Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall.

    Code Info

    UDI-DI: 00809708121860; Lot Numbers: 08-24092-60 08-24093-60 08-24094-60 08-24095-60 08-24096-60

    Distribution

    US Nationwide. Canada.

    Quantity

    1292 units