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Alere Scarborough, Inc.

2 recalls •
🏥 Medical Devices
• Categories: Diagnostic Equipment

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.

Class I - Dangerous

Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit

Jun 26, 2015 Diagnostic Equipment Nationwide View Details →

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.

Class I - Dangerous

High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.

Apr 22, 2015 Diagnostic Equipment Nationwide View Details →