BEUDAMED
    FDA Recall Terminated

    Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322.

    Recall: Z-0736-2007 · Initiated March 16, 2007

    Recall

    Recall Number
    Z-0736-2007
    Event Number
    37599
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    KXT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2007
    Posted
    April 13, 2007
    Terminated
    June 12, 2008
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322.

    Reason

    The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 ng/mL for all reagent lots.

    Action

    A recall letter dated 3/16/07 was sent to each consignee advising them that the LDL claim in the label has been revised to 0.3 ng/ml for all reagent lots.

    Distribution

    Nationwide.

    Quantity

    4,735