Alere Scarborough, Inc. dba Binax, Inc. - Alere i Influenza A & B - Class 2 Recall

Alere i Influenza A & B Product Usage: 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.
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts