Device recall
Z-1546-2026: Owner's Booklets and Instructions for Use that are used with the following blood…
FDA device recall · Class I · Trividia Health, Inc.
Key facts
| Recall number (Z-number) | Z-1546-2026 |
|---|---|
| Recall event | 98317 |
| 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… |
| Product code | NBW |
| Recalling firm | Trividia Health, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K140100 |
| FEI number | 1000113657 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database