BEUDAMED
    FDA Recall Terminated

    Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216.

    Recall: Z-0574-06 · Initiated February 10, 2006

    Recall

    Recall Number
    Z-0574-06
    Event Number
    34590
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LFW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 10, 2006
    Posted
    February 28, 2006
    Terminated
    June 23, 2006
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216.

    Reason

    May have tobramycin over-recovery at the trough level.

    Action

    Consignees were notified via phone and faxed recall letter on or about 2/10/06.

    Distribution

    Nationwide.

    Quantity

    1806 kits