Z-2095-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2015
- Initiation Date
- June 26, 2015
- Termination Date
- September 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 257 Kits
Product Description
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.
Reason for Recall
Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit
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.
Code Information
Lot Number 0073853 (US distribution only)