BEUDAMED
    FDA Enforcement Class III Terminated

    Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a test kit containing characterized positive and negative controls intended for use in qualitative procedures as external quality control material for the Remel Xpect Flu A&B test kit.

    Recall: Z-1962-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1962-2013
    Event ID
    64711
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2013
    Initiation Date
    February 19, 2013
    Classification Date
    August 13, 2013
    Termination Date
    August 14, 2013
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States

    Description

    Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a test kit containing characterized positive and negative controls intended for use in qualitative procedures as external quality control material for the Remel Xpect Flu A&B test kit.

    Reason

    Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.

    Code Info

    Lot 260745, exp. 5/31/2014

    Distribution

    Nationwide distribution: AL, AR, CA, CO, CT, FL, GA, IA, IL, KS, MA, MD, MI, MO, NM, NV, NY, OH, PA, TX, WA, and WI.

    Quantity

    96 kits of 20 swab sets