Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0910-2014·Announced 2014-02-12

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: Nipro Diagnostics, Inc.
Category: Medical Device — Blood Glucose Monitor
Hazard: mis-labeling
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same manufacturer · Nipro Diagnostics, Inc.

See all →

Moderate
Nipro Diagnostics Recalls Blood Glucose Monitors With Incorrect Factory Settings
FDA (Devices) · 2014-02-12
Moderate
Nipro TRUEtrack Blood Glucose Monitor Kits Recalled for Labeling Error
FDA (Devices) · 2013-04-24

Same hazard · mis labeling