BEUDAMED
    FDA Enforcement Class II 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 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1140-2013
    Event ID
    64499
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nipro Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    February 25, 2013
    Classification Date
    April 18, 2013
    Termination Date
    July 8, 2013
    Address
    2400 NW 55th Ct, N/A, Ft Lauderdale, FL, 33309-2672, United States

    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.

    Code Info

    Finished Good (FG) Kit Lot# KL01009-3TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01009-12TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01233-4TI, TRUEtrack Test Strip Lot# RL3476; FG Kit Lot# KM0548TI, TRUEtrack Test Strip Lot# RM3547; FG Kit Lot# KM0645TI, TRUEtrack Test Strip Lot# RM3562; FG Lot# KM0692TI, TRUEtrack Test Strip Lot# RM3562.

    Distribution

    Nationwide Distribution only in NY.

    Quantity

    1,627 Kits