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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: PN 425-024, LN 0072633 (United States Distribution) and PN 425-000, LN 0073888 (distributed in Hong Kong, Singapore - evaluation use only)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Alere Scarborough, Inc. dba Binax, Inc.
- Reason for Recall:
- High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
PN 425-024, LN 0072633 (United States Distribution) and PN 425-000, LN 0073888 (distributed in Hong Kong, Singapore - evaluation use only)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1677-2015
Related Recalls
Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit