BEUDAMED
    FDA Recall 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 · Initiated October 3, 2012

    Recall

    Recall Number
    Z-0182-2013
    Event Number
    63387
    Firm
    Focus Diagnostics Inc
    FEI Number
    2023365
    Product Code
    NOP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 3, 2012
    Posted
    October 31, 2012
    Terminated
    December 4, 2012
    Address
    11331 Valley View St, Cypress, CA, 90630-5366

    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.

    Action

    Focus Diagnostics Inc., sent a Urgent Medical Device Recall letter dated October 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you received at least one of the effected lots in the month of August 2012. Please document the number of kits in your inventory on the table below, even if zero (0), and fax to 562-240-6526. For further questions please call (714) 220-1900.

    Distribution

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

    Quantity

    425 units