The Recall Desk
SevereFDA (Devices)·Z-1545-2026·Announced 2026-03-18

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

Trividia Health is recalling owner's booklets and instructions for TRUE METRIX 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 blood glucose measuring devices, covering retailer-branded kits including Walgreens, Leader, CVS, GNP, Meijer, Fred's, Discount Drug, Kinray, HEB, McKesson, Sunmark, Signature Care, CareOne, Rite Aid, Liberty, Humana and Wegmans versions. About 12,067,458 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 devices and their UDI-DIs are listed individually in the FDA enforcement record.

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 Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GN
Manufacturer
Trividia Health, Inc.
Category
Medical Device — Blood glucose monitoring
Hazard
  • inadequate-instructions
  • treatment-delay
  • labelling-error
  • class-i-recall

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 (20)

  • Device Item/UDI-DI: RE4001-01/00311917166896
  • RE4002-01/96295126600
  • RE4002-40/96295126655
  • RE4007-01SB/50428275283
  • RE4011-00/87701426520
  • RE4011-01/87701426254
  • RE4019-01/713733069816
  • RE4023-01/21292007256
  • RE4025-01/93351018992
  • RE4027-01/21292007065
  • RE4031-01/41220001286
  • RE4051-43/20612479197231
  • RE4054-00/10939722447
  • RE4054-01/10939719447
  • RE4060-01/321130788669
  • RE4061-01/41520147745
  • RE4066-01/11822445610
  • RE4078-40/21292007614
  • RE4081-03/21292014797
  • RE4087-01/77890394113

Distribution

Distributed nationwide across the United States.

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