Alere i Influenza A & B Product Usage: The Alere i Influenza A and B… — Class II medical device recall Z-1677-2015
Terminated recall by Alere Scarborough, Inc. dba Binax, Inc., reported 2015-06-03, distributed nationwide. High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A
| Recall number | Z-1677-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alere Scarborough, Inc. dba Binax, Inc., Scarborough, ME, United States |
| Recall initiated | 2015-04-22 |
| Classified | 2015-05-27 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2016-01-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK, SG |
Product
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.
Reason for recall
High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1677-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.