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.
FDA Recall Z-1140-2013 · Posted 2013-04-18
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Recalling FirmNipro Diagnostics, Inc.
Recall StatusTerminated
Product CodeNBW
Date Initiated2013-02-25
Date Terminated2013-07-08
Product Quantity1,627 Kits
Reason for Recall
Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
Firm 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.
Root Cause
Environmental control
Distribution Pattern
Nationwide Distribution only in NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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