Device recall
Z-1386-2012: ACCU-CHEK Aviva Nano Blood Glucose Meter No product labeling, beyond the labels…
FDA device recall · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-1386-2012 |
|---|---|
| Recall event | 61405 |
| Product | ACCU-CHEK Aviva Nano Blood Glucose Meter No product labeling, beyond the labels applied to the meter, was provided with the meter as these meters were never intended to be distributed. A representative copy of product labeling that would have been included in a finished device kit is attached. The… |
| Product code | NBW |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 6, 2012 |
| 510(k) numbers | K113137 |
| FEI number | 1823260 |
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