Medical device recalls Moderate risk

Trividia Health, Inc. recalls TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of gluco…

Recall date
April 20, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2201-2020
FDA classification
Class II
Brand / firm
Trividia Health, Inc.
Sold / distributed
US Nationwide distribution including in the state of Florida.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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