Owner’s Booklets and Instructions for Use that are used with the following blood glucose measuring devices
Medical device recall Z-1548-2026. Published in FDA’s Enforcement Report on Mar 18, 2026.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 18, 2026. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 1,407,465 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
1,407,465, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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,…
Every code shown here, 1,075 characters
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.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 6, 2026.
- FDA classified it on Mar 12, 2026.
- FDA’s Enforcement Report published it on Mar 18, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Trividia Health, Inc., of Fort Lauderdale, FL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.