Device 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 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.
Z-1677-2015
Product summary
- Event
- Event 71059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 213 kits plus 3 - evaluation use only kits
- Official record key
device-enforcement:Z-1677-2015
Official wording
Reason: High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
Code information: PN 425-024, LN 0072633 (United States Distribution) and PN 425-000, LN 0073888 (distributed in Hong Kong, Singapore - evaluation use only)
Distribution pattern: Worldwide Distribution - US Nationwide in the states of AL CA CT FL IA ID IL IN KY LA MD MO MS NC NE NJ OH PA SC TN TX and the countries of: Hong Kong and Singapore.
Derived failure modes
-
Unknown
High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.