BEUDAMED
    FDA Recall 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 · Initiated June 26, 2015

    Recall

    Recall Number
    Z-2095-2015
    Event Number
    71585
    Firm
    Alere Scarborough, Inc. dba Binax, Inc.
    FEI Number
    1221359
    Product Code
    OCC
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 26, 2015
    Posted
    July 16, 2015
    Terminated
    September 15, 2015
    Address
    10 Southgate Rd, Scarborough, ME, 04074-8303

    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

    Action

    Alere sent a Urgent Medical Device Recall letter dated June 26, 2015, to all affected consignees. Customers were instructed to cease use and discard any unused pouched Sample Receivers and Transfer Cartridges contained in Alere" i Influenza A & B PN 425-024, Lot 0073853. Pouched Sample Receivers and Transfer Cartridges are identified in the kit as part number 425-431 lot number 074005 or 074108. Replacement Sample Receivers and Transfer Cartridges will be provided to the customer. Customers with questions were instructed to call Alere Technical Services at 855-731-2288 or email [email protected].

    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