BEUDAMED
    FDA Recall Terminated

    Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. 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-0443-2016 · Initiated November 6, 2015

    Recall

    Recall Number
    Z-0443-2016
    Event Number
    72525
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JTN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 6, 2015
    Terminated
    February 13, 2017
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. 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

    Antibiotic concentration may be insufficient which may result in incorrect test results.

    Action

    ThermoFisher Scientific sent an Urgent Medical Device Recall letter dated November 6, 2015, to all affected customers via first class mail. The recall notice identified the problem with the device and asked customers to inspect their stocks for the affected lots. The notice instructed customers to destroy any remaining inventory from the affected lots, contact the recalling firm for replacement, and complete the accompanying Acknowledgement form. Customers with questions were instructed to contact the Technical Services Departmentn at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-895-4077.

    Distribution

    Nationwide Distribution including IL, GA, FL, NC, CA, AL, MA, IN, MO, NY, TX, VA, KS, and IA. Product was also distributed to Puerto Rico.

    Quantity

    58/5/50 discs/catridges/packs