FDA Device recall Z-1677-2015
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 vi…
- FDA Device
- Class II
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of 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 vi… by Alere Scarborough, citing high invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1677-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-22 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alere Scarborough |
| Distribution | US |
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
High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
Identifiers
| code_info | PN 425-024, LN 0072633 (United States Distribution) and PN 425-000, LN 0073888 (distributed in Hong Kong, Singapore - evaluation use only) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1677-2015%22
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