Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alere i flu Recalled by Alere Scarborough, Inc. dba Binax, Inc. Due to Risk of false negative results due to microbial...
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 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.
Quantity: 257 Kits
Why Was This Recalled?
Risk of false negative results due to microbial growth in the Sample Receiver of one lot 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