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Alere Scarborough, Inc. dba Binax, Inc. recalls Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is
Recalled June 3, 2015 · FDA recall Z-1677-2015 · Alere Scarborough, Inc.
Hazard
High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit. · FDA Class II
Units
213 kits plus 3 - evaluation use only kits
Sold at
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.
Description
High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
Product
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.
Manufacturer(s)
Alere Scarborough, Inc. dba Binax, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →