Device recall
Z-2766-2019: Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood…
FDA device recall · Class II · Roche Diabetes Care, Inc.
Key facts
| Recall number (Z-number) | Z-2766-2019 |
|---|---|
| Recall event | 83574 |
| Product | Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus… |
| Product code | NBW |
| Recalling firm | Roche Diabetes Care, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 30, 2020 |
| 510(k) numbers | K133862 |
| 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