Recall Z-1140-2013 ยท NBW System, Test, Blood Glucose, Over The Counter
Nipro Diagnostics, Inc.
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.
| Date | Apr 18, 2013 (initiated Feb 25, 2013) |
| Status | Terminated |
| Reason | Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range. |
| 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 954-677-9 |
| Quantity | 1,627 Kits |
| Distribution | Nationwide Distribution only in NY. |
| FDA record | Open on fda.gov |