BEUDAMED
    FDA Enforcement Class II Terminated

    Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

    Recall: Z-1677-2015 · Reported June 3, 2015

    Enforcement

    Recall Number
    Z-1677-2015
    Event ID
    71059
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alere Scarborough, Inc. dba Binax, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2015
    Initiation Date
    April 22, 2015
    Classification Date
    May 27, 2015
    Termination Date
    January 14, 2016
    Address
    10 Southgate Rd, Scarborough, ME, 04074-8303, United States

    Description

    Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

    Reason

    High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.

    Code Info

    PN 425-024, LN 0072633 (United States Distribution) and PN 425-000, LN 0073888 (distributed in Hong Kong, Singapore - evaluation use only)

    Distribution

    Worldwide Distribution - US Nationwide in the states of AL CA CT FL IA ID IL IN KY LA MD MO MS NC NE NJ OH PA SC TN TX and the countries of: Hong Kong and Singapore.

    Quantity

    213 kits plus 3 - evaluation use only kits