Device recall
Z-2187-2018: Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no…
FDA device recall · Class II · Roche Diabetes Care, Inc.
Key facts
| Recall number (Z-number) | Z-2187-2018 |
|---|---|
| Recall event | 80018 |
| Product | Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or… |
| Product code | LFR |
| Recalling firm | Roche Diabetes Care, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 16, 2020 |
| 510(k) numbers | K131029 |
| FEI number | 3011393376 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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