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U.S. Department of Health and Human Services

Class 2 Device Recall Poly stat Flu A & B Test

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  Class 2 Device Recall Poly stat Flu A & B Test see related information
Date Initiated by Firm March 09, 2012
Date Posted August 31, 2012
Recall Status1 Terminated 3 on October 14, 2014
Recall Number Z-2307-2012
Recall Event ID 62537
510(K)Number K083746  
Product Classification Antigens, cf (including cf control), influenza virus a, b, c - Product Code GNX
Product Poly stat Flu A & B Test
Manufactured for
Polymedco
510 Furnace Dock Road
Cortlandt Manor, NY 10567
Tel 800-431-2123
914-739-5400
Fax 914-739-5890.


The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Code Information 510 k K083746  Catalog Number FLU22 Lot numbers 441A11, 441C11
Recalling Firm/
Manufacturer		 Princeton Biomeditech Corp
4242 US Highway 1
Monmouth Junction NJ 08852-1905
For Additional Information Contact Ms. Kyung-ah Kim, PhD
732-274-1000 Ext. 133
Manufacturer Reason
for Recall		 There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action OraSure Technologies, Inc. sent an "IMPORTANT NOTICE FOR ORASURE QUICKFLU RAPID FLU A + B TEST" letter dated March 13, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 610-882-1820 for questions concerning this recall.
Quantity in Commerce 103 kits (22 tests per kit)
Distribution Nationwide Distribution-including the states of NJ, NY, and PA.
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 = GNX and Original Applicant = PRINCETON BIOMEDITECH CORP.
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