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

[pending] Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring d

Pending LLM rewrite. Source: FDA_DEVICE Z-1545-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

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 — Devices

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.

Related recalls

Same category