FDA · Medical devicesClass IMar 18, 2026

Trividia Health, Inc. medical device recall: Owner's Booklets and Instructions for Use that are used with the…

Key facts

Agency: U.S. Food and Drug Administration (FDA)
Program: Medical devices
Classification: Class I
Status: Ongoing
Event ID: 98317
Recall initiated: Feb 6, 2026
Classified by FDA: Mar 12, 2026
Posted in Enforcement Report: Mar 18, 2026
Recalling firm: Trividia Health, Inc.
Firm location: Fort Lauderdale, FL, United States
Initiated by: Voluntary: Firm initiated
Firm notified customers by: Letter
Products in this event: 4

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

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.

What the classification means

Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Feb 6, 2026. FDA classified it 34 days later, on Mar 12, 2026. This recall event covers 4 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia. Trividia Health, Inc. has 4 recalls in our records.

Recalled products (4)

Z-1545-2026 Class I Ongoing

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GNP TRUE METRIX Meter Only/RE4011-00, GNP TRUE METRIX Kit /RE4011-01, MEIJER TRUE METRIX Kit/RE4019-01, FRED'S TRUE METRIX Kit/RE4023-01, DISCOUNT DRUG TRUE METRIX Kit/RE4025-01, KINRAY TRUE METRIX Kit/RE4027-01, HEB TRUE METRIX Kit/RE4031-01, McKesson TRUE METRIX Starter Kit/RE4051-43, SUNMARK TRUE METRIX Meter Only/RE4054-00, SUNMARK TRUE METRIX Kit/RE4054-01, Signature Care TRUE METRIX Kit/RE4060-01, CareOne TRUE METRIX Kit/RE4061-01, RITE AID TRUE METRIX Kit/RE4066-01, Liberty TRUE METRIX Meter Only/RE4078-40, HUMANA TRUE METRIX Starter Kit/RE4081-03, Wegmans TRUE METRIX Kit/RE4087-01, HEALTHMART TRUE METRIX Meter Only/RE4089-00, HEALTHMART TRUE METRIX Kit/RE4089-01, ARRIVA TRUE METRIX Meter Only/RE4095-40, HealthyAccents TRUE METRIX Kit/RE4097-01, Shopko TRUE METRIX Kit/RE4098-01, Henry Schein TRUE METRIX Kit/RE4099-40, Henry Schein TRUE METRIX Meter Only/RE4099-45, Millennium Pharmay Services TRUE METRIX…
Codes / lots: Device Item/UDI-DI: RE4001-01/00311917166896, RE4002-01/96295126600, RE4002-40/96295126655, RE4007-01SB/50428275283, RE4011-00/87701426520, RE4011-01/87701426254, RE4019-01/713733069816, RE4023-01/21292007256, RE4025-01/93351018992, RE4027-01/21292007065, RE4031-01/41220001286, RE4051-43/20612479197231, RE4054-00/10939722447, RE4054-01/10939719447, RE4060-01/321130788669, RE4061-01/41520147745, RE4066-01/11822445610, RE4078-40/21292007614, RE4081-03/21292014797, RE4087-01/77890394113, RE4089-00/52569138557, RE4089-01/52569138526, RE4095-40/21292007041, RE4097-01/725439988933, RE4098-01/21292008901, RE4099-40/21292014902, RE4099-45/21292008697, RE4202-43/21292007454, RE4203-01/41260016028, RE4209-01/36800234529, RE4211-01/10939958693, RE4H01-00/21292006082, RE4H01-01/21292006051, RE4H01-04/21292008895, RE4H01-40/21292006068, RE4H01-43/21292006075, RE4H01-51/21292014940. International:…
Quantity: 12,067,458
Z-1546-2026 Class I Ongoing

Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE METRIX PRO Meter Only/RE4099P-40, Henry Schein TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01.
Codes / lots: Device Item/UDI-DI: RE4H01P-40/21292006099, RE4H01P-43/21292006105, RE4212P-00/10840330705681, RE4099P-40/21292014919, RE4099P-43/21292008673, RE4051P-00/20612479197217, RE4068P-01/607415261097. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX PRO Owners Booklet/RE4TVHP03 Rev 56 and prior, McKesson Med Surg TRUE METRIX PRO Owners Booklet/ RE4SUNP03 Rev 56 and prior, Device serial numbers: Prefix "TP" followed by a seven-digit numeric sequence.
Quantity: 1,001,534
Z-1547-2026 Class I Ongoing

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 -…
Codes / lots: 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)/…
Quantity: 3,678,026
Z-1548-2026 Class I Ongoing

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01, HEB TRUE METRIX GO Kit/RF4031-01, Hyvee TRUE METRIX GO Kit/RF4048-01, Rite Aid TRUE METRIX GO Kit/RF4066-01, TopCo TRUE METRIX GO Kit/RF4209-01, TRUE METRIX GO Kit/RF4H01-01BK, TRUE METRIX GO NFRS Meter Only/RF4H01-40, TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK, TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK
Codes / lots: Device Item/UDI-DI: RF4001-01BK/311917178691, RF4007-01/50428560402, RF4019-01/708820721098, RF4023-01/21292009335, RF4031-01/41220136131, RF4048-01/75450843576, RF4066-01/11822002783, RF4209-01/36800234567, RF4H01-01BK/21292006112, RF4H01-40/21292009793. International: RF4i29-11BK/N/A, RF4i81-11BK/N/A, RF4i82-11BK/21292012229, RF4i82-12BK/21292009984. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX GO Owner's Booklet/ RF4TVH03 Rev 57 and prior, TRUE METRIX GO Owner's Booklet (English)/RF4TVH35 Rev 51 and prior, TRUE METRIX GO Owner's Booklet (Spanish)/RF4TVH35S Rev 51 and prior, TRUE METRIX GO Blood Glucose Monitoring System IFU Trividia House Brand/ RF4ITV16 Rev 55 and prior, TRUE METRIX GO System Instructions for Use (IFU) for Trividia Health UK Limited/ RF4UKT16 Rev 56 and prior, Trividia Health LATAM- TRUE METRIX GO System IFU/ RF4LAT16 Rev 51 and prior, TRUE…
Quantity: 1,407,465

Source and freshness

Source: U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice: FDA Enforcement Report, event 98317
Raw record: openFDA API (JSON)
Dataset last updated by FDA: Nov 3, 2026
Imported by RecallRadar: Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.