Z-1677-2015Class II

Alere i Influenza A & B

Name: Z-1677-2015 Alere i Influenza A & B
Creator: Alere Scarborough, Inc. dba Binax, Inc.
Published: 2015-04-22
License: https://open.fda.gov/license/

Abbott Diagnostics Scarborough, Inc. / initiated 2015-04-22 / Terminated

FDA source

Alere Scarborough, Inc. dba Binax, Inc. began a recall of 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... on 2015-04-22. FDA classified it as Class II and gives the reason as "High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1677-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-22
Posted: 2015-05-26
Terminated: 2016-01-14
Recalling firm: Abbott Diagnostics Scarborough, Inc.
Product: 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.
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
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.
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 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.
Product codes and lots: PN 425-024, LN 0072633 (United States Distribution) and PN 425-000, LN 0073888 (distributed in Hong Kong, Singapore - evaluation use only)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1677-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1677-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-27

Product code OCC

K141520Class IIAlere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc. / cleared 2014-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)