Device recall
Z-3128-2026: StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
FDA device recall · Class I · Nova Biomedical Corporation
Key facts
| Recall number (Z-number) | Z-3128-2026 |
|---|---|
| Recall event | 99546 |
| Product | StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. |
| Product code | PZI |
| Recalling firm | Nova Biomedical Corporation |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K232075 |
| FEI number | 1219029 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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