Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 3, 2015
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 c
High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
Alere Scarborough, Inc. dba Binax, Inc. recalled Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed… - a moderate-severity action.
Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed… was recalled by Alere Scarborough, Inc. dba Binax, Inc. in June 3, 2015. Reason: High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza …. Check the official notice for the remedy. Verify recall #Z-1677-2015 with the FDA Devices before acting.
The recall
Alere Scarborough, Inc. dba Binax, Inc. issued this moderate-severity FDA Devices recall-High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza ….
- Moderate
- severity level
- Class II
- classification
- June 3, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1677-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1677-2015) was formally reported on June 3, 2015, with the manufacturer initiating the action on April 22, 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 list the affected scope as 213 kits plus 3 - evaluation use only kits.
The documented reason for this recall is: High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
213 kits plus 3 - evaluation use only kits
Related Recalls
6
3 from same agency
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.
Reason for recall
High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1677-2015 |
| Date reported | June 3, 2015 |
| Date initiated | April 22, 2015 |
| Recalling firm | Alere Scarborough, Inc. dba Binax, Inc. |
| Firm location | Scarborough, ME |
| Affected scope | 213 kits plus 3 - evaluation use only kits |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1677-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Alere Scarborough, Inc. dba Binax, Inc.. Units affected: 213 kits plus 3 - evaluation use only kits.
Why was this product recalled? ▼
High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2015. Severity: Moderate. Recall number: Z-1677-2015.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1677-2015) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 3, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.