Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7… recallZ-1140-2013 · Nipro Diagnostics, Inc. · initiated Feb 25, 2013
Class II Terminated All recalls posted in April 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nipro Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
FDA root cause category: Environmental control
What the company is doing
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.
Recall details
- Recall number
- Z-1140-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 25, 2013
- Posted by the FDA
- Apr 18, 2013
- Recalling firm
- Nipro Diagnostics, Inc.
- Quantity
- 1,627 Kits
- Product code
- NBW
- FDA submissions
- K030703, K032657
- 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.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
20 devices cleared under K030703, K032657 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TRUEtrack TRUEtrack BLOOD GLUCOSE MONITORING SYSTEMTrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter81 reports
- TRUEtrack TRUEtrack Blood Glucose Monitoring SystemTrividia Health, Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)41 reports
- TRUEtrack TRUEtrack blood glucose monitorTrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter34 reports
- TRUEtrack TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM NOT FOR RETAIL SALETrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter28 reports
- TRUEtrack TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLYTrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter16 reports
- TRUEtrack TRUEtrack 25 Blood Glucose Test StripsTrividia Health, Inc. · Glucose Oxidase, Glucose16 reports
- TRUEtrack TRUEtrack BLOOD GLUCOSE MONITORING SYSTEMTrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter11 reports
- TRUEtrack TRUEtrack blood glucose monitoring systemTrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter9 reports
- TRUEtrack TRUEtrack Blood Glucose Meter FREE METER ONLYTrividia Health, Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)9 reports
- TRUEtrack TRUEtrack 10 Blood Glucose Test StripsTrividia Health, Inc. · Glucose Oxidase, Glucose8 reports
- TRUEtrack TRUEtrack Blood Glucose Monitoring SystemTrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter7 reports
- TRUEtrack TRUEtrack Blood Glucose Monitoring SystemTrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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