FDAFDA · Food and drugs·Recall number Z-1140-2013
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.
Published April 24, 2013 · Recall initiated: February 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nipro Diagnostics, Inc.
- Distributor
- Nationwide Distribution only in NY.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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