Trividia True Metrix Air Blood Glucose Meter Recall for Unit Error
One True Metrix Air blood glucose meter is being recalled because it displays results in mmol/L instead of mg/dL.
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 hazard involves a labeling/measurement error that could lead to incorrect medical decisions, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Trividia Health, Inc. is recalling one (1) TRUE METRIX AIR blood glucose meter. The device was distributed in the United States, including in the state of Florida, and was packaged into a TRUE METRIX blood glucose meter kit.
The recall is due to an incorrect factory-set unit of measure. The meter displays glucose results in mmol/L rather than the standard mg/dL, which could lead to misinterpretation of blood glucose levels.
Consumers who have this specific meter, identified by Serial Number TA1548753, should stop using it and contact Trividia Health, Inc. for instructions on how to proceed.
The recalled product
- Product
- TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
- Manufacturer
- Trividia Health, Inc.
- Affected units
- 1
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 (1)
- Serial Number TA1548753
Distribution
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