BEUDAMED
    FDA Recall Terminated

    Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma.

    Recall: Z-2001-2009 · Initiated April 22, 2009

    Recall

    Recall Number
    Z-2001-2009
    Event Number
    51896
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    DKB
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 22, 2009
    Posted
    September 10, 2009
    Terminated
    December 7, 2009
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma.

    Reason

    The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.

    Action

    Roche Diagnostics Corp. notified Consignees via letter dated April 22, 2009 and instructed to not use excessive force when opening bottles and contact the firm for product replacement instead. A Fax Back Form was included for customers to return via fax to 1-888-345-0480. For further information, contact your Roche Diagnostics representative or call 1-800-428-5074.

    Distribution

    Nationwide Distribution

    Quantity

    3,970 bottles of both products