Nipro Diagnostics Recalls TRUEtrack Blood Glucose Monitors Due to Unit Error
Nipro Diagnostics is recalling 105 TRUEtrack blood glucose monitors because they were manufactured with an incorrect factory set unit of measure.
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, and the source text describes a manufacturing defect regarding units of measure without reporting specific injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Nipro Diagnostics, Inc. is recalling 105 units of the MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. The recall was initiated because the devices were manufactured with an incorrect factory set unit of measure.
The affected monitors are intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The recall covers specific finished goods code KJ0731 and lot numbers KK0964, KL01213, KL01233-3TI, KL0267-10, KL0381-14, KL0637-2TI, KL0716TI, KL0860TI, and KP0074TI.
The products were distributed nationwide in the United States, including Hawaii and Puerto Rico, as well as internationally to Canada, the European Union, and various other countries. Consumers should check their devices for the affected lot numbers and contact the recalling firm for instructions.
The recalled product
- Product
- MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken fr
- Manufacturer
- Nipro Diagnostics, Inc.
- Hazard
- Affected units
- 105
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 (10)
- Finished Goods: KJ0731
- Lot Numbers: KK0964
- KL01213
- KL01233-3TI
- KL0267-10
- KL0381-14
- KL0637-2TI
- KL0716TI
- KL0860TI
- KP0074TI.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Nipro Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Nipro Diagnostics, Inc.
See all →- ModerateNipro Diagnostics Recalls Blood Glucose Monitors With Incorrect Factory Settings
FDA (Devices) · 2014-02-12
- ModerateNipro TRUEtrack Blood Glucose Monitor Kits Recalled for Labeling Error
FDA (Devices) · 2013-04-24
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