FDAFDA · Food and drugs·Recall number Z-2201-2020
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.
Published June 10, 2020 · Recall initiated: April 20, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Trividia Health, Inc.
- Distributor
- US Nationwide distribution including in the state of Florida.
- Lot
- Serial Number TA1548753
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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