Z-1140-2013 Class II Terminated
FDA device recall Z-1140-2013 was initiated by Nipro Diagnostics, Inc. on February 25, 2013 and is designated Class II. Reason for recall: Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range. The recall status is terminated (terminated July 8, 2013). Affected quantity: 1,627 Kits.
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.