BEUDAMED
    FDA Recall Terminated

    Tobramycin Calibrators, REF 7F93-01; Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538; Distributed by Abbott Diagnostics, 100 Abbott Park Road, Abbott Park, Illinois 60064. .Tobramycin is a commonly used antibiotic to treat bacterial infections, in particular gram negative infections.

    Recall: Z-0773-2012 · Initiated November 11, 2011

    Recall

    Recall Number
    Z-0773-2012
    Event Number
    60503
    Firm
    Microgenics Corp
    FEI Number
    3010939897
    Product Code
    DLJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 11, 2011
    Posted
    January 17, 2012
    Terminated
    May 9, 2012
    Address
    46360 Fremont Blvd, Fremont, CA, 94538

    Description

    Tobramycin Calibrators, REF 7F93-01; Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538; Distributed by Abbott Diagnostics, 100 Abbott Park Road, Abbott Park, Illinois 60064. .Tobramycin is a commonly used antibiotic to treat bacterial infections, in particular gram negative infections.

    Reason

    Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range.

    Action

    ThermoFisher Scientific sent a product removal letter dated November 11, 2011. Letters were sent to the sole distributor of the product. The letter identified the product the problem and the action needed to be taken by the customer. If you are using or have inventory of the affected lot numbers immediately discontinue use and destroy any remaining affected lot numbers per your local waste ordinances. If you have any further questions regarding this information please call 1-877-4Abbott. Customers outside the US should contact their local customer service.

    Distribution

    Worldwide Distribution -- Nationwide Distribution including the country Europe.

    Quantity

    1366 kits