Nipro Diagnostics, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1140-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 25, 2013

Date Posted: April 24, 2013

Recall Number: Z-1140-2013

Event ID: 64499

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,627 Kits

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.

Distribution Pattern:

Nationwide Distribution only in NY.

Voluntary or Mandated:

Voluntary: Firm initiated