BEUDAMED
    FDA Enforcement Class II Terminated

    Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in- vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes

    Recall: Z-0794-2014 · Reported January 29, 2014

    Enforcement

    Recall Number
    Z-0794-2014
    Event ID
    65184
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 29, 2014
    Initiation Date
    April 9, 2013
    Classification Date
    January 21, 2014
    Termination Date
    January 21, 2014
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States

    Description

    Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in- vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes

    Reason

    Cartridges may contain individual discs which were not impregnated with antibiotic.

    Code Info

    Lot 1215912, Exp. 31Jul2015

    Distribution

    Nationwide Distribution: US including Puerto Rico.

    Quantity

    80 packs