# FDA recall Z-1546-2026

> **Trividia Health, Inc.** · Class I · device recall initiated 2026-02-06.

## 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 METRIX PRO Meter Only/RE4099P-40,  Henry Schein TRUE METRIX PRO Kit/RE4099P-43,  McKESSON  TRUE METRIX PRO Meter Only/RE4051P-00,  Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01.

## Reason for recall

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.

## Distribution

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

## Key facts

- **Recall number:** Z-1546-2026
- **Recalling firm:** Trividia Health, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-06
- **Report date:** 2026-03-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Lauderdale, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1546-2026

## Citation

> AI Analytics. FDA recall Z-1546-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1546-2026. Source: US FDA. Licensed CC0.

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