The Recall Desk
SevereFDA (Devices)·Z-1548-2026·Announced 2026-03-18

TRUE METRIX GO manuals recalled as Class I over E-5 error guidance

Trividia Health is recalling owner's booklets and instructions for TRUE METRIX GO blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.

Plain-English summary

Trividia Health, Inc. is recalling owner's booklets and instructions for use supplied with TRUE METRIX GO blood glucose measuring devices, covering retailer-branded kits including Walgreens, CVS, Meijer, Fred's Pharmacy, HEB, Hy-Vee, Rite Aid and TopCo versions, plus international kits for Jamaica, Australia and the United Kingdom. About 1,407,465 units were distributed worldwide, covering the United States nationwide including Puerto Rico, and Mexico, the United Kingdom, Jamaica, Trinidad & Tobago and Australia.

The system labeling, in both the user manual and online, did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions do not clearly emphasise that an E-5 error code could represent a very high blood glucose level, and do not 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. The FDA has classified this recall as Class I, its most serious category.

Affected booklets and instructions are identified by part number and revision, including RF4TVH03 Rev 57 and prior, RF4TVH35 Rev 51 and prior, RF4ITV16 Rev 55 and prior, RF4UKT16 Rev 56 and prior and RF4LAT16 Rev 51 and prior.

Users can identify affected documentation by the part number and revision printed on it, and may contact Trividia Health, Inc. for further information.

The recalled product

Product
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/R
Manufacturer
Trividia Health, Inc.
Category
Medical Device — Blood glucose monitoring
Hazard
Affected units
1,407,465

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • 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
  • TRUE METRIX GO Owner's Booklet (English)/RF4TVH35 Rev 51 and prior
  • TRUE METRIX GO Owner's Booklet (Spanish)/RF4TVH35S Rev 51 and prior
  • Trividia Health LATAM- TRUE METRIX GO System IFU/ RF4LAT16 Rev 51 and prior

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Trividia Health, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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