Trividia Health, Inc.: 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

Recall number

Z-1547-2026

Recalling firm

Trividia Health, Inc.

Product

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

Status

Open, Classified

Initiated

2026-02-06

Posted

2026-03-12

Terminated

not on file

Reason

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.

Root cause

Software design

Action

On 2/6/2026, press was issued and correction notices were emailed to customers. E-5 Error Code in the Messages section of the Owner's Booklets/System Instructions for Use emphasizes that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose. Customers: notify your customers immediately of the correction and to include the letter in their notification, and to ask that they notify their customers or facilities if they have further distributed the Products. Retail pharmacies: post the notice in areas where the Products are sold to notify patients. Multiple Patient Facilities: post the notice in areas where the Products are stored to notify personnel. People with Diabetes are asked to follow the updated E-5 error code instructions Visit www.trividiahealth.com for updated Owner's Booklets and help resources. Complete and return the acknowledgement form via email to trividia0126CS@trividiahealth.com Firm Customer Care Department: 1-888-835-2723, trividia0126CC@trividiahealth.com or visit www.trividiahealth.com/E-5productnotice , which has links to Owner's Booklets, correction notice, and press. On 5/5/2026, updated correction notices were mailed to customers informing them of the following: For people with diabetes, if possible, consider transitioning to an alternative method of testing your blood glucose. People with Diabetes who rely on intensive insulin therapy, sulfonylureas, or glucose monitoring due to frequent hypo- or hyperglycemia events should consider transitioning to an alternative testing method until the updated devices with updated software becomes available. Firm will notify users when the upgrade program becomes available. The firm asked customers to handle dissemination of the updated notice and completion/return of the acknowledgement form as stated above. Affected serial number search tool is located at www.trividiahealth.com/E-5productnotice

Quantity

3,678,026

Distribution

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

Lot, serial or model codes

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. Device serial numbers: Prefixes "TB" or "TA" followed by a seven-digit numeric sequence.

510(k) numbers

["K150052"]

PMA numbers

not on file

Product code

NBW

Firm FEI

1000113657

Firm city

Fort Lauderdale

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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