BEUDAMED
    FDA Enforcement Class III Terminated

    Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.

    Recall: Z-2081-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2081-2013
    Event ID
    64852
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    March 25, 2013
    Classification Date
    August 26, 2013
    Termination Date
    June 3, 2014
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States

    Description

    Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.

    Reason

    Use of affected lots may give false indication of susceptibility to Nitrofurantoin.

    Code Info

    Lots 1194944 and 1198342

    Distribution

    US Distribution including the states of AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA.

    Quantity

    60 packs