BEUDAMED
    FDA Recall Terminated

    HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera.

    Recall: Z-1764-2008 · Initiated July 6, 2007

    Recall

    Recall Number
    Z-1764-2008
    Event Number
    47459
    Firm
    Focus Diagnostics Inc
    FEI Number
    2023365
    Product Code
    LGC
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 6, 2007
    Posted
    August 17, 2008
    Terminated
    June 25, 2009
    Address
    10703 Progress Way, Cypress, CA, 90630-4714

    Description

    HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera.

    Reason

    A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.

    Action

    Focus notified all clients which received the recalled lots starting on July 6, 2007 via an Important Medical Device Information letter by fax or email. The letter explains how to identify suspect results and the steps to be taken if suspect results are obtained. If customers find the interpretation of results with the indicated kit lots to be problematic, customers have the option of having their kits replaced at no charge within 90 days of receiving the notification.

    Distribution

    Worldwide Distribution --- USA including states of OH, CA, CT, IL, NY, and countries of Barbados, Canada, Germany, Israel, Slovakia, France, and England.

    Quantity

    Lot Code 063169 - 97 Kits, Lot Code 063354 - 16 Kits, Lot Code 063355 - 74 Kits