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U.S. Department of Health and Human Services

Class 2 Device Recall Alere i flu, Alere i, Alere Influenza A & B

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 Class 2 Device Recall Alere i flu, Alere i, Alere Influenza A & Bsee related information
Date Initiated by FirmJune 26, 2015
Date PostedJuly 16, 2015
Recall Status1 Terminated 3 on September 15, 2015
Recall NumberZ-2095-2015
Recall Event ID 71585
510(K)NumberK141520 
Product Classification Respiratory virus panel nucleic acid assay system - Product Code OCC
ProductAlere 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 Lot Number 0073853 (US distribution 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		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 Determined
Cause 2		Process change control
ActionAlere 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 ts.scr@alere.com.
Quantity in Commerce257 Kits
DistributionNationwide 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.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OCC
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