Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

© 2026 Go Backs. All rights reserved.

Critical RiskFDA Device
Medical Devices/Home Healthcare

TRUE METRIX Blood Glucose System Recalled for Inadequate Error Guidance

Agency Publication Date: March 12, 2026
Share:
Sign in to monitor this recall

Summary

Trividia Health is recalling approximately 18.2 million owner's booklets and instructions for several TRUE METRIX blood glucose monitoring systems. The instructions do not adequately explain that an 'E-5' error code on the meter may indicate a life-threateningly high blood sugar level. The manuals also fail to instruct users to seek immediate medical attention when this error occurs. These systems were sold at major retailers including Walgreens, CVS, Walmart, Rite Aid, and Kroger.

Risk

If a user has very high blood sugar and receives an E-5 error code, they may not realize they are in a medical emergency. This can lead to a dangerous delay in seeking treatment, potentially resulting in serious health complications or death from untreated high glucose.

What You Should Do

  1. Check your blood glucose system to see if it is a TRUE METRIX, TRUE METRIX PRO, TRUE METRIX AIR, or TRUE METRIX GO model.
  2. Locate your Owner's Booklet or Instructions for Use and check the part number and revision level on the back cover. This recall affects various revisions including RE4TVH03 Rev 56 and prior, REA4TVH03 Rev 57 and prior, and RF4TVH03 Rev 57 and prior. See the Affected Products section below for the full list of affected codes.
  3. Stop using the current instructions and contact Trividia Health or your healthcare provider for updated guidance on how to respond to an E-5 error code.
  4. If you receive an E-5 error code on your meter and are experiencing symptoms of high blood sugar (such as extreme thirst, frequent urination, or blurred vision), contact a healthcare professional immediately.
  5. Return the product to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or the manufacturer for further instructions.
  6. For additional questions, call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

You have 2 options:

💰Option 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
🗑️Option 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: TRUE METRIX Blood Glucose Monitoring System Instructions
Variants: Standard, PRO, AIR, GO, English, Spanish
Model / REF (98):
RE4001-01
RE4002-01
RE4002-40
RE4007-01SB
RE4011-00
RE4011-01
RE4019-01
RE4023-01
RE4025-01
RE4027-01
RE4031-01
RE4051-43
RE4054-00
RE4054-01
RE4060-01
RE4061-01
RE4066-01
RE4078-40
RE4081-03
RE4087-01
RE4089-00
RE4089-01
RE4095-40
RE4097-01
RE4098-01
RE4099-40
RE4099-45
RE4202-43
RE4203-01
RE4209-01
RE4211-01
RE4H01-00
RE4H01-01
RE4H01-04
RE4H01-40
RE4H01-43
RE4H01-51
RE4i01-00
RE4i01-01
RE4i01-02
RE4i03-02
RE4i03-11
RE4i05-00
RE4i07-00
RE4i23-00
RE4i29-11
RE4i61-02
RE4i61-02THI
RE4i82-11
RE4i82-12
UPC Codes (83):
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
21292006099
21292006105
10840330705681
21292014919
21292008673
20612479197217
607415261097
311917173894
96295129267
50428354766
Lot Numbers:
RE4TVH03 Rev 56 and prior
RE4TVH35 Rev 51 and prior
RE4TVH35S Rev 51 and prior
RE4SUN03 Rev 55 and prior
RE4SUNP03 Rev 56 and prior
RE4ITV16 Rev 53 and prior
RE4UKT16 Rev 55 and prior
RE4LAT16 Rev 50 and prior
RE4AUT16 Rev 56 and prior
RE4TVHP03 Rev 56 and prior
REA4TVH03 Rev 57 and prior
REA4TVH35 Rev 51 and prior
REA4TVH35S Rev 51 and prior
REA4RLN03 Rev 52 and prior
REA4RLN35 Rev 52 and prior
REA4ITV03 Rev 55 and prior
REA4UKT03 Rev 55 and prior
REA4LAT03 Rev 51 and prior
REA4AUT03 Rev 58 and prior
RF4TVH03 Rev 57 and prior
RF4TVH35 Rev 51 and prior
RF4TVH35S Rev 51 and prior
RF4ITV16 Rev 55 and prior
RF4UKT16 Rev 56 and prior
RF4LAT16 Rev 51 and prior
RF4AUT16 Rev 57 and prior
UDI (83):
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
21292006099
21292006105
10840330705681
21292014919
21292008673
20612479197217
607415261097
311917173894
96295129267
50428354766

Includes various store-branded meters such as Walgreens, CVS, Leader, GNP, Meijer, and Rite Aid.

Product Images

"Image of E-5 error code on screen"

"Image of E-5 error code on screen"

"Image of E-5 error code on screen"

"Image of E-5 error code on screen"

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98317
Status: Active
Manufacturer: Trividia Health, Inc.
Sold By: Walgreens; CVS; Walmart; Rite Aid; Meijer; Publix; HEB; Kroger; Hyvee; Henry Schein; McKesson; TopCare; Leader; Good Neighbor Pharmacy; Fred's Pharmacy; Discount Drug Mart; Kinray; Sunmark; Signature Care; CareOne; Liberty; Humana; Wegmans; Healthmart; Arriva; HealthyAccents; Shopko; Millennium Pharmacy Services; Foster and Thrive; Moore Medical
Manufactured In: United States
Units Affected: 4 products (12,067,458; 1,001,534; 3,678,026; 1,407,465)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.