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FDA recall, , High risk

Trividia Health TRUE METRIX Blood Glucose Meter Owner's Booklets and Instructions

The labeling for True Metrix blood glucose meters does not adequately explain the E-5 error code, which could delay treatment.

Summary by Recall Canary from the FDA notice

What happened

The instructions for TRUE METRIX blood glucose meters fail to emphasize seeking immediate medical attention for an E-5 error with high glucose symptoms. This could delay treatment and lead to serious adverse health consequences or death.

2 photos

What to do

If a code on your device is listed below:

  1. DISPLAY: SEE IMAGE BELOW, REASON: Very high blood glucose / result (higher than 600 mg/dL), / Or Test Strip Error, ACTION: WARNING!! / Retest with a new test strip. / If the error persists and you have symptoms / such as fatigue, excess urination, thirst or / blurry vision, seek medical attention / immediately. / If you are not experiencing symptoms, retest / with a new test strip.
  2. If the error persists, call / 1-800-803-6025, Monday - Friday, 8AM-8PM / EST for assistance.
  3. UPDATED E-5 INSTRUCTIONS for TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO: UPDATED E-5 INSTRUCTIONS for TRUE METRIX PRO: If you have any questions relating to the Owner’s Booklets/System Instructions for Use update, please call Trividia Health Customer Care Department toll-free at 1-888-835-2723 Monday - Friday 8AM-8PM EST (excluding holidays) or e-mail trividia0126CC@trividiahealth.com or visit www.trividiahealth.com/E-5productnotice.
  4. You may continue to use the TRUE METRIX® Products.

Is yours affected?

2 products

Match your product and all the details in one listed combination.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Owner's Booklets and Instructions for Use that

    1. UDI-DI
      • 21292006099
      • 21292006105
      • 10840330705681
      • 21292014919
      • 21292008673
      • 20612479197217
      • 607415261097
      Recall number
      Z-1546-2026
    2. UDI-DI
      • 311917173894
      • 96295129267
      • 50428354766
      • 87701427398
      • 708820685659
      • 41415072787
      • 93351022784
      • 41220009169
      • 10939742445
      • 11822590051
      • 21292015015
      • 21292007164
      • 21292007584
      • 52569139042
      • 681131240154
      • 681131403214
      • 41260007354
      • 10939958617
      • 21292007010
      • 21292007447
      • 21292007911
      • 21292012731
      • 21292012212
      • 21292009991
      Recall number
      Z-1547-2026
    3. UDI-DI
      • 311917178691
      • 50428560402
      • 708820721098
      • 21292009335
      • 41220136131
      • 75450843576
      • 11822002783
      • 36800234567
      • 21292006112
      • 21292009793
      • 21292012229
      • 21292009984
      Recall number
      Z-1548-2026
    4. UDI-DI
      • 00311917166896
      • 96295126600
      • 96295126655
      • 50428275283
      • 87701426520
      • 87701426254
      • 713733069816
      • 21292007256
      • 93351018992
      • 21292007065
      • 41220001286
      • 20612479197231
      • 10939722447
      • 10939719447
      • 321130788669
      • 41520147745
      • 11822445610
      • 21292007614
      • 21292014797
      • 77890394113
      • 52569138557
      • 52569138526
      • 21292007041
      • 725439988933
      • 21292008901
      • 21292014902
      • 21292008697
      • 21292007454
      • 41260016028
      • 36800234529
      • 10939958693
      • 21292006082
      • 21292006051
      • 21292008895
      • 21292006068
      • 21292006075
      • 21292014940
      • 21292010133
      • 21292012205
      • 21292009977
      Recall number
      Z-1545-2026
  2. Reason
    Very high blood glucose result (higher than 600 mg/dL), Or Test Strip Error
    Action
    WARNING!! Retest with a new test strip. If the error persists and you have symptoms such as fatigue, excess urination, thirst or blurry vision, seek medical attention immediately. If you are not experiencing symptoms, retest with a new test strip. If the error persists, call 1-800-803-6025, Monday - Friday, 8AM-8PM EST for assistance.

Recall details

Company announced
Sold in

LAUDERDALE, FL) – February 6, 2026 – Trividia Health, Inc., announced today that it is initiating a labeling correction which requires a modification of the Owner’s Booklets/System Instructions for Use for all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monitoring Systems (collectively, the “Products”) distributed in the United States, United Kingdom, Mexico, Australia, and the Caribbean. The correction affects all TRUE METRIX branded Blood Glucose Meters distributed in the United States, United Kingdom, Mexico, Australia and the Caribbean.

Company
Trividia Health, Inc.
Risk

High risk

There is a reasonable chance that using it could cause serious health problems or death.

FDA Class I recall · How risk is rated

FDA record

More from Trividia Health

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)