RegWardenFDA facility compliance records
Company

TRIVIDIA HEALTH, INC.

4 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2016: 1 recalls; 2020: 1 recalls; 2025: 1 recalls; 2026: 1 recalls120162017201820191202020212022202320241202512026
  • Recalls (4)

Registered facilities (2)

Recalls & enforcement

  • Class IOngoing2026-02-06
    The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code cou…
  • Class IIOngoing2025-10-07
    Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
  • Class IITerminated2020-04-20
    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 IIOngoing2016-06-28
    Product gives incorrect low blood glucose levels.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “TRIVIDIA HEALTH, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9000560-trividia-health-inc/

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