BEUDAMED
    FDA Enforcement Class II Terminated

    Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.

    Recall: Z-0449-2015 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0449-2015
    Event ID
    69629
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2014
    Initiation Date
    October 29, 2014
    Classification Date
    November 24, 2014
    Termination Date
    June 1, 2015
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.

    Reason

    The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.

    Code Info

    Lot: 293086 Expiration 01Apr2015

    Distribution

    Worldwide Distribution to USA including AL, CA, CO, IA, MO, NC, NY, NV, OH, PA, SC, SD, TN, TX, VA, WI and Internationally to Canada.

    Quantity

    79/5/250- packages/bottles/ml