Alere Scarborough, Inc. dba Binax, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1677-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 22, 2015

Date Posted: June 3, 2015

Recall Number: Z-1677-2015

Event ID: 71059

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.

Status: Terminated

Product Quantity: 213 kits plus 3 - evaluation use only kits

Code Information:

PN 425-024, LN 0072633 (United States Distribution) and PN 425-000, LN 0073888 (distributed in Hong Kong, Singapore - evaluation use only)

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of AL CA CT FL IA ID IL IN KY LA MD MO MS NC NE NJ OH PA SC TN TX and the countries of: Hong Kong and Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated