BEUDAMED
    FDA Enforcement Class III Terminated

    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.

    Recall: Z-0182-2013 · Reported November 7, 2012

    Enforcement

    Recall Number
    Z-0182-2013
    Event ID
    63387
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Focus Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 7, 2012
    Initiation Date
    October 3, 2012
    Classification Date
    October 31, 2012
    Termination Date
    December 4, 2012
    Address
    11331 Valley View St, N/A, Cypress, CA, 90630-5366, United States

    Description

    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.

    Reason

    The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.

    Code Info

    Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117.

    Distribution

    Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.

    Quantity

    425 units