FDA-Device2026-03-18Class IMISBRANDING

TRUE METRIX GO blood glucose meters recalled for unclear E-5 error instructions

FALSE CLAIMSNationwide distribution

Check your TRUE METRIX GO meter instructions

The instruction manuals for TRUE METRIX GO blood glucose meters sold at Walgreens, CVS, Meijer, and other retailers do not clearly explain what an E-5 error code means or what you should do about it. An E-5 error can indicate a dangerously high blood glucose level, and the instructions should tell you to contact a healthcare professional right away.

If your TRUE METRIX GO meter shows an E-5 error, contact your doctor or healthcare provider immediately, especially if you feel symptoms of high blood sugar
Check if your meter's instruction booklet is revision 57 or earlier (or revision 51 or earlier for Spanish versions)
Visit the FDA website or contact Trividia Health for updated instructions

Hazard

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.

Sold states

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

Affected count

1,407,465

Manufactured in

3230 W Prospect Rd, N/A, Fort Lauderdale, FL, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1548-2026

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