FDA-Device2020-06-10Class II
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.
Trividia Health, Inc.
Hazard
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.
Sold states
US Nationwide distribution including in the state of Florida.
Affected count
1 unit
Manufactured in
2400 NW 55th Ct, N/A, Ft Lauderdale, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2201-2020Don't want to check this manually?
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