Alere i Influenza A & B Kit Recalled for False Negative Risk
Alere is recalling 257 kits of the Alere i Influenza A & B test due to microbial growth that may cause false negative results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of false negative results for a diagnostic test, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Alere Scarborough, Inc. dba Binax, Inc. is recalling 257 kits of the Alere i Influenza A & B assay, Part Number 425-024. The recall affects Lot Number 0073853, which was distributed nationwide to specific states 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, and WY.
The recall is being conducted because microbial growth was found in the Sample Receiver of the affected kits. This contamination poses a risk of false negative results, meaning the test may fail to detect influenza A or B viral RNA in nasal swabs from patients with respiratory symptoms.
Healthcare providers and facilities that have received this specific lot should stop using the kits and contact the manufacturer for instructions on return or disposal. The Alere i Influenza A & B assay is a rapid molecular in vitro diagnostic test intended to aid in the differential diagnosis of influenza A and B viral infections.
The recalled product
- 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 detecti
- Manufacturer
- Alere Scarborough, Inc. dba Binax, Inc.
- Affected units
- 257
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 0073853 (US distribution only)
Distribution
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