TRUE METRIX AIR
TRIVIDIA HEALTH, INC. · Model TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE SYSTEM
Humana Pharmacy TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE SYSTEM
Intended use: A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
Technical Specs
- Storage Environment Temperature
- 40°F to 86°F
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- OTC
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Glucose monitoring system IVD, home-use
- FDA product classification
- System, Test, Blood Glucose, Over The Counter
- Manufacturer support
- +1(800)803-6025 · customercare@trividiahealth.com
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
- RECALL
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
- RECALL
One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a TRUE METRIX blood glucose meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL.
- RECALL
Product gives incorrect low blood glucose levels.
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