BEUDAMED
    FDA Recall Terminated

    Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190. The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.

    Recall: Z-0970-2010 · Initiated October 7, 2009

    Recall

    Recall Number
    Z-0970-2010
    Event Number
    53546
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    LCD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 7, 2009
    Posted
    March 8, 2010
    Terminated
    December 10, 2010
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190. The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.

    Reason

    A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.

    Action

    Consignees were notified by recall letter dated October 7, 2009. The letter described the affected products, issue and instructed consignees to immediately discontinue use of the products. Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions about the information contained in the recall letter.

    Distribution

    Nationwide Distribution.

    Quantity

    13,187 of all products.