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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

Trividia Health, Inc., of Fort Lauderdale, Florida, recalled Owner's Booklets and Instructions for Use used with TRUE METRIX blood glucose measuring devices because the system labeling did not provide adequate directions for lay users to act on the E-5 error code.

The error code description and recommended actions do not clearly emphasize that an E-5 error code could represent a very high blood glucose level, nor do they prominently convey appropriate immediate actions, such as contacting a healthcare professional.

As currently written, the Owner's Booklets/System Instructions for Use fail to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose.

The recall, which began February 6, 2026, covers products distributed nationwide in the US including Puerto Rico, and in Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia. The affected products include Owner's Booklets and Instructions for Use for TRUE METRIX PRO, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX kits and meters, with quantities for each product listed in the recall. The recall was added to the FDA's Enforcement Report on March 12, 2026.

More labeling error recalls

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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.

Is yours affected?

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 began the recall
Sold in

Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.

Company
Trividia Health, Inc.Fort Lauderdale, Florida
Recalls that follow it
North American Rescue AIDBAG First Aid Kits
Hazard
Labeling error
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

Event ID
98317
Recall numbers
Z-1545-2026 to Z-1548-2026

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall · Announced by the company

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

  5. Summary updated

Press release

More medical device recalls

See all: More medical device recalls

Summary by Recall Canary, written with AI · summary updated Oct 7, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)