The Recall Desk

FDA (Devices) recall action 98317

Trividia Health, Inc. recalled 4 products on 2026-03-18

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2026-03-18
Critical
0
Units
18,154,483

Why these products were recalled

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 glu…

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • SevereFDA (Devices)··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.

    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
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··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.

    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
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2026-03-18

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

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

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2026-03-18

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

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

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE MET
    Category
    Distribution
    1 state