Owner's Booklets and Instructions for Use that are used with the… — Class I medical device recall Z-1546-2026
Ongoing recall by Trividia Health, Inc., reported 2026-03-18, distributed nationwide. The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act
| Recall number | Z-1546-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trividia Health, Inc., Fort Lauderdale, FL, United States |
| Recall initiated | 2026-02-06 |
| Classified | 2026-03-12 |
| Reported by FDA | 2026-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, GB, JM, MX, TT |
| Quantity | 1,001,534 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00607415261097, 10840330705681, 20612479197217 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1546-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.