Device product
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.
Z-2095-2015
Product summary
- Event
- Event 71585
- Status
- Terminated
- Classification
- Class II
- Quantity
- 257 Kits
- Official record key
device-enforcement:Z-2095-2015
Official wording
Reason: Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit
Code information: Lot Number 0073853 (US distribution only)
Distribution pattern: Nationwide Distribution including AR CA CO CT FL GA IA IL IN KS KY LA MA MD ME MO MS NC NE NJ NY OH PA SC TX VA WA WY.
Derived failure modes
-
Microbial contamination
microbial growth