BEUDAMED
    FDA Enforcement Class II Ongoing

    Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.

    Recall: Z-1370-2026 · Reported February 25, 2026

    Enforcement

    Recall Number
    Z-1370-2026
    Event ID
    98315
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medica Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 25, 2026
    Initiation Date
    December 31, 2025
    Classification Date
    February 13, 2026
    Address
    5 Oak Park Dr, Bedford, MA, 01730-1430, United States

    Description

    Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.

    Reason

    A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.

    Code Info

    Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.

    Distribution

    International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.

    Quantity

    1,578 units