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U.S. Department of Health and Human Services

Class 2 Device Recall Duane Reade TRUEtrack monitor kit

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  Class 2 Device Recall Duane Reade TRUEtrack monitor kit see related information
Date Initiated by Firm February 25, 2013
Date Posting Updated April 18, 2013
Recall Status1 Terminated 3 on July 08, 2013
Recall Number Z-1140-2013
Recall Event ID 64499
510(K)Number K030703  K032657  
Product Classification System, test, blood glucose, over the counter - Product Code NBW
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Nipro Diagnostics, Inc.
2400 NW 55th Ct
Ft Lauderdale FL 33309-2672
For Additional Information Contact Karen DeVincent
800-342-7226 Ext. 3019
Manufacturer Reason
for Recall
Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
FDA Determined
Cause 2
Environmental control
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.
Quantity in Commerce 1,627 Kits
Distribution Nationwide Distribution only in NY.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = HOME DIAGNOSTICS, INC.
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