BEUDAMED
    FDA Recall Terminated

    Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.

    Recall: Z-1176-06 · Initiated June 7, 2006

    Recall

    Recall Number
    Z-1176-06
    Event Number
    35493
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    CIC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 7, 2006
    Posted
    June 27, 2006
    Terminated
    April 23, 2008
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.

    Reason

    Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling.

    Action

    Consignees were notified via letter dated 6/6/06 and sent via UPS to discontinue use of these lots and to destroy them. Distributors are being asked to notify their customers.

    Distribution

    Nationwide.

    Quantity

    933 kits