Events

Recall of Device Recall Duane Reade TRUEtrack monitor kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nipro Diagnostics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64499
  • Event Risk Class
    Class 2
  • Event Number
    Z-1140-2013
  • Event Initiated Date
    2013-02-25
  • Event Date Posted
    2013-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116357
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, test, blood glucose, over the counter - Product Code NBW
  • 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.

Device

Device Recall Duane Reade TRUEtrack monitor kit
  • Model / Serial
    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.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution only in NY.
  • Product 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.
  • Manufacturer
    Nipro Diagnostics, Inc.

Manufacturer

Nipro Diagnostics, Inc.
  • Manufacturer Address
    Nipro Diagnostics, Inc., 2400 NW 55th Ct, Ft Lauderdale FL 33309-2672
  • Manufacturer Parent Company (2017)
    Nipro Corporation
  • Source
    USFDA