BEUDAMED
    FDA Enforcement Class II 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 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2085-2013
    Event ID
    65770
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Life Technologies Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    May 13, 2013
    Classification Date
    August 26, 2013
    Termination Date
    August 28, 2013
    Address
    7335 Executive Way, Frederick, MD, 21704-8354, United States

    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.

    Code Info

    Catalog #18081020, Lot #1368760 & Lot #1312093

    Distribution

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

    Quantity

    15 kits