Device recall
Z-1557-2020: Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
FDA device recall · Class II · Abbott Diabetes Care, Inc.
Key facts
| Recall number (Z-number) | Z-1557-2020 |
|---|---|
| Recall event | 84866 |
| Product | Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 |
| Product code | NBW |
| Recalling firm | Abbott Diabetes Care, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| 510(k) numbers | K081975 |
| FEI number | 3002803444 |
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