Alere Scarborough, Inc. dba Binax product recalled over fire hazard

Recall date

April 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 a r…

Recall number

Z-1677-2015

FDA classification

Class II

Brand / firm

Alere Scarborough, Inc. dba Binax, Inc.

Sold / distributed

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.

Why it was recalled

High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.