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.
FDA Recall Z-2308-2012 · Posted 2012-08-31
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Recalling FirmPrinceton Biomeditech Corp
Recall StatusTerminated
Product CodeGNX
Date Initiated2012-03-09
Date Terminated2014-10-14
Product Quantity90 kits (22 tests per kit)
Reason for Recall
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution-including the states of NJ, NY, and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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