Device product
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.
Z-1140-2013
Product summary
- Event
- Event 64499
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,627 Kits
- Official record key
device-enforcement:Z-1140-2013
Official wording
Reason: Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
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.
Derived failure modes
-
Unknown
Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.