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trividia health, inc.medicalHigh PriorityActive

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.

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. was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.

By RecallRadar Editorial Team

Sourced from FDA. Last verified April 6, 2026.

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Key facts

Date announced
March 18, 2026
Source agency
FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

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. was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

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.

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand
Trividia health, inc.
Category
medical
Source agency
FDA
Announced
March 18, 2026
Country
US
Status
Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

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.

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

  1. 1Stop using the affected product until you verify whether your item is impacted.
  2. 2Check the official recall notice and match your model, lot, or serial details.
  3. 3Follow the official instructions for repair, replacement, refund, or disposal.
Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
FDA
Announced by source
March 18, 2026
Last reviewed by RecallRadar
April 6, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists 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..

What is the remedy for this recall?

Follow the official instructions for repair, replacement, refund, or disposal on the trividia health, inc. recall page.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/device/enforcement.json?search=recall_number:Z-1545-2026&limit=1

Keep browsing with these internal hubs: trividia health, inc. recall hub and Medical recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from FDA

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