Z-1140-2013Class II

Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is...

Name: Z-1140-2013 Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is...
Creator: Nipro Diagnostics, Inc.
Published: 2013-02-25
License: https://open.fda.gov/license/

Trividia Health, Inc. / initiated 2013-02-25 / Terminated / root cause: manufacturing process

FDA source

Nipro Diagnostics, Inc. began a recall of 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... on 2013-02-25. FDA classified it as Class II and gives the reason as "Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1140-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-25
Posted: 2013-04-18
Terminated: 2013-07-08
Recalling firm: Trividia Health, Inc.
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.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1140-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1140-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-18

Product code NBW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)