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U.S. Department of Health and Human Services

Class 2 Device Recall Alere i Influenza A & B

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  Class 2 Device Recall Alere i Influenza A & B see related information
Date Initiated by Firm April 22, 2015
Date Posted May 26, 2015
Recall Status1 Terminated 3 on January 14, 2016
Recall Number Z-1677-2015
Recall Event ID 71059
510(K)Number K141520  
Product Classification Respiratory virus panel nucleic acid assay system - Product Code OCC
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.
Code Information PN 425-024, LN 0072633 (United States Distribution) and PN 425-000, LN 0073888 (distributed in Hong Kong, Singapore - evaluation use only)
Recalling Firm/
Manufacturer		 Alere Scarborough, Inc. dba Binax, Inc.
10 Southgate Rd
Scarborough ME 04074-8303
For Additional Information Contact
855-731-2288
Manufacturer 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 Determined
Cause 2		 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 s.scr@alere.com. For questions regarding the status of your credit, please contact your AI ere i distributor or E-mail: ssc.alerefieldactions@alere.com.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OCC and Original Applicant = ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
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