Drug recall
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices…
FDA recall event 98317 · Class I · Trividia Health, Inc.
Key facts
| Event ID | 98317 |
|---|---|
| Recall numbers | Z-1545-2026, Z-1546-2026, Z-1547-2026, Z-1548-2026 |
| Recalling firm | Trividia Health, Inc. |
| Product type | Devices |
| Products | 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…, 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…, 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…, 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… |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 6, 2026 |
| Report date | Mar 18, 2026 |
| City | Fort Lauderdale |
| State | FL |
| Country | United States |
| FEI number | 1000113657 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: