Date Initiated by Firm | March 09, 2012 |
Date Posted | August 31, 2012 |
Recall Status1 |
Terminated 3 on October 14, 2014 |
Recall Number | Z-2308-2012 |
Recall Event ID |
62537 |
510(K)Number | K083746 |
Product Classification |
Antigens, cf (including cf control), influenza virus a, b, c - Product Code GNX
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Product | Status Flu A + B Test
Manufactured by
Princeton Bio Meditech Corporation
Monmouth Junction, NJ 08852 USA.
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 36022 Lot numbers 441H11 90 kits (22 tests per kit) |
Recalling Firm/ Manufacturer |
Princeton Biomeditech Corp 4242 US Highway 1 Monmouth Junction NJ 08852-1905
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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 | 90 kits (22 tests per kit) |
Distribution | Nationwide Distribution-including the states of NJ, NY, and PA. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = GNX
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