BEUDAMED
    FDA Enforcement Class II Terminated

    CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.

    Recall: Z-1284-2021 · Reported March 31, 2021

    Enforcement

    Recall Number
    Z-1284-2021
    Event ID
    87445
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CAIRE DIAGNOSTICS INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 31, 2021
    Initiation Date
    February 26, 2021
    Classification Date
    March 19, 2021
    Termination Date
    March 24, 2023
    Address
    7020 Koll Center Pkwy, N/A, Pleasanton, CA, 94566-3103, United States

    Description

    CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.

    Reason

    Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readings: 1) Drift in the calibration gases and 2) Software error. Each of these issues can cause FeNO scores/results to be erroneously high.

    Code Info

    All units sold before February 23, 2021 are affected (serial numbers 100107 to 100651).

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of CA, CO, FL, TX, and WI. In the countries of Belgium, Canada, Croatia/Hrvatska, France, Germany, Greece, Hong Kong, India, Philippines, Spain, Spain and Switzerland.

    Quantity

    381 units (171 units U.S. and 210 units O.U.S.)