Recall Z-1677-2015— Alere Scarborough, Inc. dba Binax, Inc.

Name: FDA recall Z-1677-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-22

Class II · Terminated

Class II FDA medical device recall by Alere Scarborough, Inc. dba Binax, Inc., initiated 2015-04-22, terminated 2016-01-14. It names one FDA 510(k) clearance: K141520. 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..

Recalling firm: Alere Scarborough, Inc. dba Binax, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-22
Terminated: 2016-01-14
Firm location: Scarborough, ME, United States

510(k) clearances named in this recall

1 on FDA's record

K141520 — ALERE I INFLUENZA A & BAlere Scarborough, Inc D/B/A Binax, Inc.·cleared 2014-06-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.