Facility

Trividia Health, Inc.

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

Key facts

4recalls · worst Class I

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000113657
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Repack or Relabel Medical Device; Complaint File Establishment per 21 CFR 820.198
Location	2400 NW 55TH CT Fort Lauderdale, FL, US 33309
Registration status	Active · expires 2026
Parent company	TRIVIDIA HEALTH, INC. (owner-operator 9000560)
Brand names	TRUEmanager; SmartData

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

System, Test, Blood Glucose, Over The Counter
Product code NBW (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345

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.

FDA inspections (1)

VAI2017-06-22
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Trividia Health, Inc. (FEI 1000113657) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000113657-trividia-health-inc/

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