BEUDAMED
    FDA Recall Terminated

    Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. 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-0734-2014 · Initiated November 21, 2013

    Recall

    Recall Number
    Z-0734-2014
    Event Number
    67099
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JTN
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    November 21, 2013
    Posted
    January 14, 2014
    Terminated
    December 11, 2014
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. 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

    Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.

    Action

    Oxoid and Remel part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The letter asked customers to destroy the affected product, if any was found on hand. The letter also asked if the customer further distributed the product that they inform their downstream customers. A response form was included with the letter and the letter instructed customers to complete and return the response form to indicate they had received the notification and that they had complied with it. If you have any questions please contact our Technical Service Department at 800-255-6730 (US) or 913-888-0939 (International).

    Distribution

    Nationwide Distribution including the states of AL, AZ, CA, CO, FL, HI, IA, IL, KY, LA, MD, MI, MN, MO, MS, NC, NY, OH, SC, TN, TX, VA, WI, and WV

    Quantity

    45/5/50 - discs/cartridges/packs