BEUDAMED
    FDA Recall Open, Classified

    Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.

    Recall: Z-1370-2026 · Initiated December 31, 2025

    Recall

    Recall Number
    Z-1370-2026
    Event Number
    98315
    Firm
    Medica Corporation
    FEI Number
    1220972
    Product Code
    CEM
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 31, 2025
    Posted
    February 13, 2026
    Address
    5 Oak Park Dr, Bedford, MA, 01730-1430

    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.

    Action

    An URGENT FIELD SAFETY NOTICE was sent to consignees on 01/09/25 informing them that potassium results obtained using affected devices in capillary mode may be falsely elevated. The FSN instructed consignees not to report potassium results obtained in capillary mode using affected lots on the Easy Stat Analyzer. The FSN is to be forwarded to end users and to where product was further distributed. Consignees are to contact their local representative with any questions.

    Distribution

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

    Quantity

    1,578 units