BEUDAMED
    FDA Enforcement Class II 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 · Reported September 12, 2012

    Enforcement

    Recall Number
    Z-2306-2012
    Event ID
    62537
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Princeton Biomeditech Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 12, 2012
    Initiation Date
    March 9, 2012
    Classification Date
    August 31, 2012
    Termination Date
    October 14, 2014
    Address
    4242 US Highway 1, N/A, Monmouth Junction, NJ, 08852-1905, United States

    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.

    Code Info

    510 k K083746 Catalog Number 1001-0320 - 22 test kits Catalog 1001-0322 - 12 test kits

    Distribution

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

    Quantity

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