Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay Recalled by Alere Scarborough, Inc. dba Binax, Inc. Due to High invalid rate and an increased risk of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alere Scarborough, Inc. dba Binax, Inc. directly.
Affected 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.
Quantity: 213 kits plus 3 - evaluation use only kits
Why Was This Recalled?
High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alere Scarborough, Inc. dba Binax, Inc.
Alere Scarborough, Inc. dba Binax, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report