--- title: "Owner's Booklets and Instructions for Use that are used with the following bl... — FDA record Z-1545-2026 | Is It on Recall" description: "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" url: https://isitonrecall.com/recall/fda-device-z-1545-2026-owner-s-booklets-and-instructions-for-use-that-are-used-with-the-following-blood-glucose-measuring-d/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Descripti... — FDA record Z-1545-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Feb 6, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: 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 Kit/RE4202-43, Kroger TRUE METRIX Kit/RE4203-01, TOPCARE TRUE METRIX Kit/RE4209-01, Foster and Thrive TRUE METRIX Kit/RE4211-01, TRUE METRIX Meter Only/RE4H01-00, TRUE METRIX Kit/RE4H01-01, TRUE METRIX Starter Kit/RE4H01-04, TRUE METRIX NFRS Meter Only/RE4H01-40, TRUE METRIX NFRS Starter Kit/RE4H01-43, TRUE METRIX Kit/RE4H01-51, TRUE METRIX Meter Only (mg/dL)/RE4i01-00, TRUE METRIX Kit (mg/dL)/RE4i01-01, TRUE METRIX Kit (mg/dL)/RE4i01-02, TRUE METRIX Starter Kit (mg/dL)/RE4i03-02, TRUE METRIX Kit (mmol/L)/RE4i03-11, Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00, Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00, TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00, TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11, TRUE METRIX Kit (mg/dL)/RE4i61-02, TRUE METRIX Kit (mg/dL)/RE4i61-02THI, TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11, TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12. - **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. - **Classification**: Class I - **Recalling firm**: Trividia Health, Inc. - **Quantity**: 12,067,458 - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1545-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1545-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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: RE4i01-00/N/A, RE4i01-01/N/A, RE4i01-02/N/A, RE4i03-02/N/A, RE4i03-11/N/A, RE4i05-00/N/A, RE4i07-00/N/A, RE4i23-00/21292010133, RE4i29-11/N/A, RE4i61-02/N/A, RE4i61-02THI/N/A, RE4i82-11/21292012205, RE4i82-12/21292009977. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX Owner's Booklet/ RE4TVH03 Rev 56 and prior, TRUE METRIX Owner's Booklet (English)/ RE4TVH35 Rev 51 and prior, TRUE METRIX Owner's Booklet (Spanish)/ RE4TVH35S Rev 51 and prior, McKesson Med Surg TRUE METRIX Self Monitoring Owners Booklet/ RE4SUN03 Rev 55 and prior, McKesson Med Surg TRUE METRIX PRO Owners Booklet/ RE4SUNP03 Rev 56 and prior, TRUE METRIX Blood Glucose Monitoring System IFU Trividia House Brand/ RE4ITV16 Rev 53 and prior, TRUE METRIX System Instructions for Use (IFU) for Trividia Health UK Limited/RE4UKT16 Rev 55 and prior, Trividia Health LATAM - TRUE METRIX System IFU mg/dL/ RE4LAT16 Rev 50 and prior, TRUE METRIX System Instructions for Use (IFU) for Trividia Health Australia/ RE4AUT16 Rev 56 and prior. Device serial numbers: Prefix "T" followed by an eight-digit numeric sequence. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Mar 18, 2026 - **Recall initiation date**: Feb 6, 2026 - **Center classification date**: Mar 12, 2026 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1545-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Trividia Health, Inc. records](https://isitonrecall.com/brand/trividia-health-inc/)