Alere i flu, Alere i, Alere Influenza A & B recallZ-2095-2015 · Alere Scarborough, Inc. dba Binax, Inc. · initiated Jun 26, 2015
Class II Terminated All recalls posted in July 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
Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit
FDA root cause category: Process change control
What the company is doing
Alere sent a Urgent Medical Device Recall letter dated June 26, 2015, to all affected consignees. Customers were instructed to cease use and discard any unused pouched Sample Receivers and Transfer Cartridges contained in Alere" i Influenza A & B PN 425-024, Lot 0073853. Pouched Sample Receivers and Transfer Cartridges are identified in the kit as part number 425-431 lot number 074005 or 074108. Replacement Sample Receivers and Transfer Cartridges will be provided to the customer. Customers with questions were instructed to call Alere Technical Services at 855-731-2288 or email [email protected].
Recall details
- Recall number
- Z-2095-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 26, 2015
- Posted by the FDA
- Jul 16, 2015
- Recalling firm
- Alere Scarborough, Inc. dba Binax, Inc.
- Quantity
- 257 Kits
- Product code
- OCC
- FDA submissions
- K141520
- Distribution
- 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.
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.
Code information (models, lots, serial numbers)
Lot Number 0073853 (US distribution 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.
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