Device recall
Z-2354-2021: Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number…
FDA device recall · Class II · Roche Diabetes Care, Inc.
Key facts
| Recall number (Z-number) | Z-2354-2021 |
|---|---|
| Recall event | 88362 |
| Product | Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001 |
| Product code | NBW |
| Recalling firm | Roche Diabetes Care, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K121679 |
| FEI number | 3011393376 |
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