Recall Z-2201-2020— Trividia Health, Inc.

Name: FDA recall Z-2201-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-20

Class II · Terminated

Class II FDA medical device recall by Trividia Health, Inc., initiated 2020-04-20, terminated 2021-06-01. It names one FDA 510(k) clearance: K150052. 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: 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..

Recalling firm: Trividia Health, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-04-20
Terminated: 2021-06-01
Firm location: Ft Lauderdale, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K150052 — TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring SystemNipro Diagnostics, Inc.·cleared 2015-03-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.