BEUDAMED
    FDA Enforcement Class II Terminated

    Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.

    Recall: Z-0846-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0846-2014
    Event ID
    67213
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Focus Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 5, 2014
    Initiation Date
    January 10, 2014
    Classification Date
    January 28, 2014
    Termination Date
    October 15, 2014
    Address
    11331 Valley View St, Cypress, CA, 90630-5366, United States

    Description

    Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.

    Reason

    Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate.

    Code Info

    Model Number MOL2650 Lot Numbers: 24493, 24495, 24535, 24536.

    Distribution

    Worldwide Distribution - US (Nationwide) including states of: NY, MA, NJ, OH, CA, HI, CO, MN, FL, PA, IA, WI, AZ, TX, TN, IL, SD, MO, NM, AR, WV, MI and Internationally to: Sweden, Israel, Canada, and Slovenia. .

    Quantity

    1,052 kits