FDA recall Z-2201-2020

Trividia Health, Inc. · Class II · device

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.

Reason for 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.

Distribution

US Nationwide distribution including in the state of Florida.

Key facts

Status
Terminated
Initiation date
2020-04-20
Report date
2020-06-10
Termination date
2021-06-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ft Lauderdale, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2201-2020