Reported Mar 18, 2026 · Ongoing
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices.…
Trividia Health, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Trividia Health, Inc. · 2400 Nw 55th Ct · Fort Lauderdale, FL · 33309-2672
Is this the product you have?
- Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices
- Description/ItemWalgreens 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
- Lot codes and dates
- Device Item/UDI-DI
RF4001-01BK/311917178691RF4007-01/50428560402RF4019-01/708820721098RF4023-01/21292009335RF4031-01/41220136131RF4048-01/75450843576RF4066-01/11822002783RF4209-01/36800234567RF4H01-01BK/21292006112RF4H01-40/21292009793
- International
RF4i29-11BK/N/ARF4i81-11BK/N/ARF4i82-11BK/21292012229RF4i82-12BK/21292009984. Owner's Booklet
- or IFU Description/Part and RevisionTRUE 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 numbersPrefix "F" followed by an eight-digit numeric sequence
- Device Item/UDI-DI
- Amount recalled
- 1,407,465
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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