BEUDAMED
    FDA Recall Terminated

    HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.

    Recall: Z-2085-2013 · Initiated May 13, 2013

    Recall

    Recall Number
    Z-2085-2013
    Event Number
    65770
    Firm
    Life Technologies Corporation
    FEI Number
    3003335080
    Product Code
    NYQ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 13, 2013
    Posted
    August 26, 2013
    Terminated
    August 28, 2013
    Address
    7335 Executive Way, Frederick, MD, 21704-8354

    Description

    HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.

    Reason

    Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.

    Action

    Life Technologices sent an Urgent Product Recall letter dated May 13, 2013 by certified mail to all affected customers. The letter identified the product, description of problem, and actions to be taken by the user. Customers were instructed to examine inventory immediately, discontinue use and dispose all affected units. Customers were advised to complete the Customer Response Sheet included for product/quantities consumed, and send e-mail to [email protected]. For questions about the details of this product issue, were instructed to contact Technical Support at 800-955-6288 option 4.

    Distribution

    USA Nationwide Distribution in the states of DE, IA, MN, and NC.

    Quantity

    15 kits