CLASS I ONGOING Device recall · Reported 18 Mar 2026 · FDA Enforcement Report

Owner's Booklets and Instructions for Use that are used recalled

Trividia Health is recalling Owner's Booklets and Instructions for Use that are used with the following blood glucose, distributed nationwide in the US. The recall was initiated on 6 Feb 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesDevice 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 METRIX GO System Instructions for Use (IFU) for Trividia Health Australia/ RF4AUT16 Rev 57 and prior. Device serial numbers: Prefix "F" followed by an eight-digit numeric sequence.

Quantity recalled1,407,465

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1548-2026
FDA event ID: 98317
Recalling firm: Trividia Health, Fort Lauderdale, FL
Classification: Class I
Status: Ongoing
Recall initiated: 6 Feb 2026
FDA classified: 12 Mar 2026
Reported: 18 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Insulin Pumps & Glucose Monitors

Timeline

6 Feb 2026	Recall initiated by company
12 Mar 2026	Classified by FDA	+34 days
18 Mar 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Puerto Rico

Stores named: H-E-B, Meijer, Walgreens, CVS, Rite Aid, Hy-Vee

Questions about this recall

Why was it recalled?

Which lots are affected?

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 METRIX GO System Instructions for Use (IFU) for Trividia Health Australia/ RF4AUT16 Rev 57 and prior. Device serial numbers: Prefix "F" followed by an eight-digit numeric sequence.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 98317

This product is part of a recall event; the main page for the event is Owner's Booklets and Instructions for Use that are used recalled.

Reported	Class	Recall	Company	Reason	Where
18 Mar 2026	CLASS I	Owner's Booklets and Instructions for Use that are used recalled	Trividia Health	Device Malfunction	Nationwide
18 Mar 2026	CLASS I	Owner's Booklets and Instructions for Use that are used recalled	Trividia Health	Device Malfunction	Nationwide
18 Mar 2026	CLASS I	Owner's Booklets and Instructions for Use that are used recalled	Trividia Health	Device Malfunction	Nationwide

More recalls from Trividia Health

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Reported	Class	Recall	Company	Reason	Where
18 Mar 2026Device	CLASS I	Owner's Booklets and Instructions for Use that are used recalled	Trividia Health	Device Malfunction	Nationwide
18 Mar 2026Device	CLASS I	Owner's Booklets and Instructions for Use that are used recalled	Trividia Health	Device Malfunction	Nationwide
18 Mar 2026Device	CLASS I	Owner's Booklets and Instructions for Use that are used recalled	Trividia Health	Device Malfunction	Nationwide
5 Nov 2025Device	CLASS II	Good Neighbor Pharmacy, True Metrix Self Monitoring Blood recalled	Trividia Health	Device Malfunction	Nationwide
10 Jun 2020Device	CLASS II	True Metrix Self Monitoring Blood Glucose System recalled	Trividia Health	Packaging Defects	Nationwide

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