Nipro TRUEtrack Blood Glucose Monitor Kits Recalled for Labeling Error
Nipro Diagnostics is recalling 1,627 TRUEtrack monitor kits because the outer boxes state an incorrect storage temperature range for the test strips.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a minor labeling error regarding storage temperature, which fits the criteria for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
Nipro Diagnostics, Inc. is recalling 1,627 units of the Duane Reade TRUEtrack monitor kit. The product is a blood glucose system intended for the quantitative determination of glucose in human whole blood to assist in the management of diabetes.
The recall was initiated because the meter kit outer boxes containing 10-count test strips state an incorrect storage temperature range. The affected lots include FG Kit Lot# KL01009-3TI, KL01009-12TI, KL01233-4TI, KM0548TI, and KM0692TI, paired with specific test strip lots.
The products were distributed nationwide, specifically within New York. Consumers who have these kits should check their lot numbers against the list provided by the manufacturer and contact Nipro Diagnostics for instructions on how to proceed.
The recalled product
- 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 h
- Manufacturer
- Nipro Diagnostics, Inc.
- Hazard
- Affected units
- 1,627
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Finished Good (FG) Kit Lot# KL01009-3TI
- TRUEtrack Test Strip Lot# RL3435
- FG Kit Lot# KL01009-12TI
- 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
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