BEUDAMED
    FDA Recall Terminated

    Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

    Recall: Z-1140-2013 · Initiated February 25, 2013

    Recall

    Recall Number
    Z-1140-2013
    Event Number
    64499
    Firm
    Nipro Diagnostics, Inc.
    FEI Number
    1000113657
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    February 25, 2013
    Posted
    April 18, 2013
    Terminated
    July 8, 2013
    Address
    2400 NW 55th Ct, Ft Lauderdale, FL, 33309-2672

    Description

    Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

    Reason

    Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.

    Action

    NIPRO Diagnostics sent a Voluntary Product Field Action Notice dated August 12, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check with all Duane Reade retail locations and Duane Reade Disgtribution Center to determine if they have any of the affected product ath their location. If product is located customers were instructed to call 1-800-803-6049 for a Return Authorization Number and instructions for returning the affected product. For questions regarding this recall call 954-677-9201.

    Distribution

    Nationwide Distribution only in NY.

    Quantity

    1,627 Kits