Alere i Influenza A & B kits recalled for false negative risk
Alere Scarborough, Inc. is recalling specific lots of Alere i Influenza A & B kits due to a high invalid rate and increased risk of false negative results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a diagnostic device with an increased risk of false negative results, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Alere Scarborough, Inc. dba Binax, Inc. is recalling specific lots of the Alere i Influenza A & B kits. The product is a rapid molecular in vitro diagnostic test used to detect and discriminate influenza A and B viral RNA in nasal swabs from patients with respiratory symptoms.
The recall is being conducted because of a high invalid rate and an increased risk of false negative results associated with certain lots of the kit. The affected products include 213 kits plus 3 evaluation use only kits. The distribution pattern includes nationwide distribution in the United States in the states of AL, CA, CT, FL, IA, ID, IL, IN, KY, LA, MD, MO, MS, NC, NE, NJ, OH, PA, SC, TN, and TX, as well as in Hong Kong and Singapore.
Healthcare providers and laboratories should stop using the affected lots immediately. Users should check their inventory for the specific product numbers and lot numbers listed in the recall notice: PN 425-024, LN 0072633 (United States Distribution) and PN 425-000, LN 0073888 (distributed in Hong Kong, Singapore - evaluation use only).
The recalled product
- 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 inf
- Manufacturer
- Alere Scarborough, Inc. dba Binax, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- PN 425-024
- LN 0072633 (United States Distribution) and PN 425-000
- LN 0073888 (distributed in Hong Kong
- Singapore - evaluation use only)
Distribution
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