FDA-Device2015-06-03Class II
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 c
Alere Scarborough, Inc. dba Binax, Inc.
Hazard
High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
Sold states
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.
Affected count
213 kits plus 3 - evaluation use only kits
Manufactured in
10 Southgate Rd, Scarborough, ME, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1677-2015Don't want to check this manually?
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