BEUDAMED
    FDA Recall Terminated

    Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 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.

    Recall: Z-2306-2012 · Initiated March 9, 2012

    Recall

    Recall Number
    Z-2306-2012
    Event Number
    62537
    Firm
    Princeton Biomeditech Corp
    FEI Number
    2246703
    Product Code
    GNX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 9, 2012
    Posted
    August 31, 2012
    Terminated
    October 14, 2014
    Address
    4242 US Highway 1, Monmouth Junction, NJ, 08852-1905

    Description

    Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 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.

    Reason

    There have been reports of dual positive (Flu A + Flu B positive) results being encountered.

    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.

    Distribution

    Nationwide Distribution-including the states of NJ, NY, and PA.

    Quantity

    370 (12 tests per kit) ;2800 kits (22 tests per kit)