Home / Recalls / Nipro Diagnostics, Inc. / Z-1140-2013

Z-1140-2013 Class II Terminated

Recalled by Nipro Diagnostics, Inc. — Ft Lauderdale, FL

Recall Details

Product Type: Devices
Report Date: April 24, 2013
Initiation Date: February 25, 2013
Termination Date: July 8, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,627 Kits

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.

Reason for Recall

Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.

Distribution Pattern

Nationwide Distribution only in NY.

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.