Recall Z-2095-2015— Alere Scarborough, Inc. dba Binax, Inc.

Name: FDA recall Z-2095-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-26

Class II · Terminated

Class II FDA medical device recall by Alere Scarborough, Inc. dba Binax, Inc., initiated 2015-06-26, terminated 2015-09-15. It names one FDA 510(k) clearance: K141520. Product: 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.. Reason: Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit.

Recalling firm: Alere Scarborough, Inc. dba Binax, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-06-26
Terminated: 2015-09-15
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 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.

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

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