BEUDAMED
    FDA Recall 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 · Initiated April 22, 2015

    Recall

    Recall Number
    Z-1677-2015
    Event Number
    71059
    Firm
    Alere Scarborough, Inc. dba Binax, Inc.
    FEI Number
    1221359
    Product Code
    OCC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 22, 2015
    Posted
    May 26, 2015
    Terminated
    January 14, 2016
    Address
    10 Southgate Rd, Scarborough, ME, 04074-8303

    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.

    Action

    Alere sent an Urgent Medical Device Recall letter dated April 23, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to stop using the product and discard any unused product. Customers asked to complete and return the Verification form within 10 days to confirm receipt of the recall notification and to request credit. For questions about the information contained in the notification, contact Alere Technical Services, Monday through Friday, 8am to 8pm EST. Telephone: (855) 731-2288 or E-mail: t [email protected]. For questions regarding the status of your credit, please contact your AI ere i distributor or E-mail: [email protected].

    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