Reported Apr 24, 2013 · Terminated
Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended…
Nipro Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nipro Diagnostics, Inc. · 2400 NW 55th Ct · Ft Lauderdale, FL · 33309-2672
Is this the product you have?
- 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.
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 Finished Good (FG) Kit Lot# KL01009-3TI, TRUEtrack Test Strip Lot# RL3435 2 FG Kit Lot# KL01009-12TI, TRUEtrack Test Strip Lot# RL3435 3 FG Kit Lot# KL01233-4TI, TRUEtrack Test Strip Lot# RL3476 4 FG Kit Lot# KM0548TI, TRUEtrack Test Strip Lot# RM3547 5 FG Kit Lot# KM0645TI, TRUEtrack Test Strip Lot# RM3562 6 FG Lot# KM0692TI, TRUEtrack Test Strip Lot# RM3562. - Amount recalled
- 1,627 Kits
Where it was sold
- Nationwide
- NY
Why it was recalled
Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
This product could cause temporary or reversible health problems — stop using it.
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