BEUDAMED
    FDA Recall Terminated

    Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Aztreonam).

    Recall: Z-0790-2013 · Initiated August 21, 2012

    Recall

    Recall Number
    Z-0790-2013
    Event Number
    63555
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JTN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 21, 2012
    Posted
    February 6, 2013
    Terminated
    June 4, 2013
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Aztreonam).

    Reason

    The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt.

    Action

    ThermoFisher sent an Important Medical Device Product Recall Notice dated August 17, 2012, to all affected customers. The letter identifed the product, the problem, and the action to be taken by the customer. Customers were instructed to review results reported using this lot and consider restesting and/or seek approproiate expert advice. Customers were requested to destroy any remaining inventory of the affected lot and contact Customer Services or their local Oxoid supplier who will issue a replacement. Customer were asked to return the attached "Acknowledgement & Receipt Form by FAX to 1-877-428-1922 or 1-913-895-4190. Customers with questions were instructed to call the Technical Support Department at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-888-0939.

    Distribution

    Nationwide Distribution including WI, MO, MA, CT, AL, IL, WA, CA, RI, MD, NJ, NC and TX.

    Quantity

    30