BEUDAMED
    FDA Enforcement Class II Terminated

    Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & 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-2095-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2095-2015
    Event ID
    71585
    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
    July 22, 2015
    Initiation Date
    June 26, 2015
    Classification Date
    July 16, 2015
    Termination Date
    September 15, 2015
    Address
    10 Southgate Rd, N/A, Scarborough, ME, 04074-8303, United States

    Description

    Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & 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

    Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit

    Code Info

    Lot Number 0073853 (US distribution only)

    Distribution

    Nationwide Distribution including AR CA CO CT FL GA IA IL IN KS KY LA MA MD ME MO MS NC NE NJ NY OH PA SC TX VA WA WY.

    Quantity

    257 Kits