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Alere I Influenza a & B

by Alere Scarborough, Inc D/B/A Binax, Inc. 510(k)

Active United States

510(k) K141520

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK141520 Date13 Jun 2014ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

3 recalls · FDA

    • Terminated Z-1231-2017 FDA Class II initiated 25 Jan 2017

    Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.

    • Terminated Z-2095-2015 FDA Class II initiated 26 Jun 2015

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

    • Terminated Z-1677-2015 FDA Class II initiated 22 Apr 2015

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

Specification

510(k)

510(k) Number
FDA Product Code
OCC
Device Class
Class II
Regulation
21 CFR Part 866.3980
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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