Devices

Device Recall Duane Reade TRUEtrack monitor kit

Model / Serial
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.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution only in NY.
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.
Manufacturer
Nipro Diagnostics, Inc.
1 Event
- Recall of Device Recall Duane Reade TRUEtrack monitor kit

Manufacturer

Nipro Diagnostics, Inc.

Manufacturer Address
Nipro Diagnostics, Inc., 2400 NW 55th Ct, Ft Lauderdale FL 33309-2672
Manufacturer Parent Company (2017)
Nipro Corporation
Source
USFDA

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