Severity
Moderate
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 vira
Reported: July 22, 2015 Initiated: June 26, 2015 #Z-2095-2015 257 Kits units
Alere Scarborough, Inc. dba Binax, Inc. issued this FDA Devices recall on July 22, 2015. Classified as Moderate severity (Class II). Approximately 257 Kits units are affected. The recall was issued because: Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-2095-2015) was formally reported on July 22, 2015, with the manufacturer initiating the action on June 26, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Alere Scarborough, Inc. dba Binax, Inc. is listed as the recalling firm, operating out of Scarborough, ME. Federal records indicate 257 Kits units are affected.
The documented reason for this recall is: Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
257 Kits
Related Recalls
6
6 from same agency
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
Details
- Recalling Firm
- Alere Scarborough, Inc. dba Binax, Inc.
- Units Affected
- 257 Kits
- 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.
- Location
- Scarborough, ME
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2095-2015 |
| Date reported | July 22, 2015 |
| Date initiated | June 26, 2015 |
| Recalling firm | Alere Scarborough, Inc. dba Binax, Inc. |
| Units affected | 257 Kits |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Alere Scarborough, Inc. dba Binax, Inc.. Units affected: 257 Kits.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 22, 2015. Severity: Moderate. Recall number: Z-2095-2015.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2095-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).