Alere i Influenza A & B recallZ-1677-2015 · Alere Scarborough, Inc. dba Binax, Inc. · initiated Apr 22, 2015
Class II Terminated All recalls posted in May 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alere Scarborough, Inc. dba Binax, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
FDA root cause category: Under Investigation by firm
What the company is doing
Alere sent an Urgent Medical Device Recall letter dated April 23, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to stop using the product and discard any unused product. Customers asked to complete and return the Verification form within 10 days to confirm receipt of the recall notification and to request credit. For questions about the information contained in the notification, contact Alere Technical Services, Monday through Friday, 8am to 8pm EST. Telephone: (855) 731-2288 or E-mail: t [email protected]. For questions regarding the status of your credit, please contact your AI ere i distributor or E-mail: [email protected].
Recall details
- Recall number
- Z-1677-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 22, 2015
- Posted by the FDA
- May 26, 2015
- Recalling firm
- Alere Scarborough, Inc. dba Binax, Inc.
- Quantity
- 213 kits plus 3 - evaluation use only kits
- Product code
- OCC
- FDA submissions
- K141520
- Distribution
- 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.
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.
Code information (models, lots, serial numbers)
PN 425-024, LN 0072633 (United States Distribution) and PN 425-000, LN 0073888 (distributed in Hong Kong, Singapore - evaluation use only)
Other devices under the same FDA submission
3 devices cleared under K141520 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ID NOW™ Instrument EQ00200XAlere Scarborough, Inc. · Real Time Nucleic Acid Amplification System44 reports
- Alere™ i Instrument EQ00200XAlere Scarborough, Inc. · Real Time Nucleic Acid Amplification System5 reports
- Alere™ i Influenza A & B 425-024Alere Scarborough, Inc. · Respiratory Virus Panel Nucleic Acid Assay System1 death1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page