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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 Owner's Booklets fail to emphasize seeking immediate medical attention for E-5 error codes with high glucose symptoms. Delayed recognition of extremely low or high blood glucose could increase risk of serious health complications or treatment delays.

What to do

If a code on your device is listed below:

  1. “The firm issued an updated press release on May 1, 2026 to advise users with diabetes to consider transitioning to an alternative method of testing their blood glucose (blood sugar).
  2. Patients continuing to use their TRUE METRIX device should follow the updated instructions if they receive an E-5 Error Code.”
  3. For People with Diabetes, if possible, consider transitioning to an alternative method of testing your blood glucose (blood sugar), otherwise you should continue using your TRUE METRIX meter.
  4. People with Diabetes who rely on intensive insulin therapy, sulfonylureas, or glucose monitoring due to frequent hypo- or hyperglycemia events are at highest risk and should consider transitioning to an alternative testing method until the updated TRUE METRIX blood glucose test system becomes available.

Call Trividia Health 1-888-943-2387

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

This updated notice affects all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO and TRUE METRIX PRO branded Blood Glucose Meters distributed in the United States.

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)