Reported Jun 3, 2015 · Terminated
Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a…
Alere Scarborough, Inc. dba Binax, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alere Scarborough, Inc. dba Binax, Inc. · 10 Southgate Rd · Scarborough, ME · 04074-8303
Is this the product you have?
- Alere i Influenza A & B Product UsageThe 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
- Lot codes and dates
- PN 425-024, LN 0072633 (United States Distribution) and PN 425-000, LN 0073888 (distributed in Hong Kong, Singapore - evaluation use only)
- Amount recalled
- 213 kits plus 3 - evaluation use only kits
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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