Alere Scarborough, Inc. dba Binax, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2095-2015)

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 flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & 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: June 26, 2015

Date Posted: July 22, 2015

Recall Number: Z-2095-2015

Event ID: 71585

Reason for Recall:

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

Status: Terminated

Product Quantity: 257 Kits

Code Information:

Lot Number 0073853 (US distribution only)

Distribution Pattern:

Nationwide Distribution including AR CA CO CT FL GA IA IL IN KS KY LA MA MD ME MO MS NC NE NJ NY OH PA SC TX VA WA WY.

Voluntary or Mandated:

Voluntary: Firm initiated