Owner's Booklets and Instructions for Use that are used with the following blood glucose measurin...
FDA Device Recall #Z-1547-2026 — Class I — February 6, 2026
Recall Summary
| Recall Number | Z-1547-2026 |
| Classification | Class I — Serious risk |
| Date Initiated | February 6, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Trividia Health, Inc. |
| Location | Fort Lauderdale, FL |
| Product Type | Devices |
| Quantity | 3,678,026 |
Product Description
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-01, Meijer TRUE METRIX AIR Kit/REA4019-01, Publix TRUE METRIX AIR Kit/REA4020-01, Discount Drug Mart TRUE METRIX AIR Kit/REA4025-01, HEB TRUE METRIX AIR Kit/REA4031-01, SunmarkTRUE METRIX AIR Kit/REA4054-01, Rite AidTRUE METRIX AIR Kit/REA4066-01, Centerwell TRUE METRIX AIR Kit/REA4081-01, HumanaTRUE METRIX AIR Meter Only/REA4081-40, Centerwell TRUE METRIX AIR Starter Kit/REA4081-43, Healthmart TRUE METRIX AIR Kit/REA4089-01, Relion TRUE METRIX AIR Kit/REA4094-01, Relion TRUE METRIX AIR Kit/REA4094-01RX, Kroger TRUE METRIX AIR Kit/REA4203-01, Foster and Thrive TRUE METRIX AIR Kit/REA4211-01, TRUE METRIX AIR Kit/REA4H01-01, TRUE METRIX AIR NFRS Meter Only/REA4H01-40, TRUE METRIX AIR NFRS Starter Kit/REA4H01-43, TRUE METRIX AIR Kit (mg/dL)/REA4i03-01, TRUE METRIX AIR Starter Kit (mg/dL)/REA4i03-02, Walmart (MediMart) TRUE METRIX AIR Meter Only (Mexico - mg/dL)/REA4i04-00, TRUE METRIX AIR Kit (Australia - mmol/L)/REA4i81-11, TRUE METRIX AIR Kit (United Kingdom - mmol/L)/REA4i82-11, TRUE METRIX AIR Starter Kit (United Kingdom - mmol/L)/REA4i82-12
Reason for Recall
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 could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Distribution Pattern
Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.
Lot / Code Information
Device Item/UDI-DI: REA4001-01/311917173894, REA4002-01/96295129267, REA4007-01/50428354766, REA4011-01/87701427398, REA4019-01/708820685659, REA4020-01/41415072787, REA4025-01/93351022784, REA4031-01/41220009169, REA4054-01/10939742445, REA4066-01/11822590051, REA4081-01/21292015015, REA4081-40/21292007164, REA4081-43/21292007584, REA4089-01/52569139042, REA4094-01/681131240154, REA4094-01RX/681131403214, REA4203-01/41260007354, REA4211-01/10939958617, REA4H01-01/21292007010, REA4H01-40/21292007447, REA4H01-43/21292007911, International: REA4i03-01/N/A, REA4i03-02/N/A, REA4i04-00/21292012731, REA4i81-11/N/A, REA4i82-11/21292012212, REA4i82-12/21292009991. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX AIR Owner's Booklet/ REA4TVH03 Rev 57 and prior, TRUE METRIX AIR Owner's Booklet (English)/ REA4TVH35 Rev 51 and prior, TRUE METRIX AIR Owner's Booklet (Spanish)/ REA4TVH35S Rev 51 and prior, Relion (Walmart) TRUE METRIX AIR Owners Booklet/ REA4RLN03 Rev 52 and prior, Relion (Walmart) TRUE METRIX AIR Owner's Booklet - English/ REA4RLN35 Rev 52 and prior, TRUE METRIX AIR Owner's Booklet International Trividia House Brand/ REA4ITV03 Rev 55 and prior, TRUE METRIX AIR Owners Booklet for Trividia Health UK Limited/ REA4UKT03 Rev 55 and prior, Trividia Health LATAM - TRUE METRIX AIR Owners Booklet/ REA4LAT03 Rev 51 and prior, TRUE METRIX AIR Owners Booklet for Trividia Health Australia/ REA4AUT03 Rev 58 and prior.
Other Recalls from Trividia Health, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1546-2026 | Class I | Owner's Booklets and Instructions for Use that ... | Feb 6, 2026 |
| Z-1548-2026 | Class I | Owner's Booklets and Instructions for Use that ... | Feb 6, 2026 |
| Z-1545-2026 | Class I | Owner's Booklets and Instructions for Use that ... | Feb 6, 2026 |
| Z-0413-2026 | Class II | Good Neighbor Pharmacy, TRUE METRIX Self Monito... | Oct 7, 2025 |
| Z-2201-2020 | Class II | TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTE... | Apr 20, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.