Nipro Diagnostics Recalls Blood Glucose Monitors With Incorrect Factory Settings
Nipro Diagnostics is recalling 501 units of the MooreBrand TRUEbalance Blood Glucose Monitor 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 does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Nipro Diagnostics, Inc. is recalling 501 units of the MooreBrand TRUEbalance Blood Glucose Monitor for Self-Testing & Multi-Patient Use. The recall is due to the devices being 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 finished good code is KK0468, and the specific lot numbers involved are KL01079, KM0337TI, KN1834TI, KN1973TI, KN2074TI, KN 2089TI, KN2090TI, KN2102TI, KP0047TI, KP0076TI, KP0128TI, and KP0925TI.
The products were distributed worldwide, including nationwide in the United States (including Hawaii and Puerto Rico) and internationally to Canada, the European Union, Jamaica, Suriname, Trinidad and Tobago, Kazakhstan, Russia, Turkey, Australia, Bangladesh, Pakistan, Cambodia, Laos, Myanmar, Thailand, Vietnam, and India. Consumers should stop using the affected devices and contact Nipro Diagnostics for instructions on how to proceed.
The recalled product
- Product
- MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. 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.
- Hazard
- Affected units
- 501
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 (13)
- Finished Good: KK0468
- Lot Numbers: KL01079
- KM0337TI
- KN1834TI
- KN1973TI
- KN2074TI
- KN 2089TI
- KN2090TI
- KN2102TI
- KP0047TI
- KP0076TI
- KP0128TI
- KP0925TI.
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 TRUEtrack Blood Glucose Monitors Due to Unit Error
FDA (Devices) · 2014-02-12
- ModerateNipro TRUEtrack Blood Glucose Monitor Kits Recalled for Labeling Error
FDA (Devices) · 2013-04-24
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