Device recall
Z-1366-06: AccuData GTS Plus for Blood Glucose Monitoring and Automated Data Management…
FDA device recall · Class II · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-1366-06 |
|---|---|
| Recall event | 35022 |
| Product | AccuData GTS Plus for Blood Glucose Monitoring and Automated Data Management including GTS Plus with Accu-Chek Advantage blood glucose meter, Cat no. 3000249 and/or GTS with Accu-Chek Advantage blood glucose meter, Cat. no. 404, and/or Replacement GTS with Accu-Chek Advantage blood gulcose meter… |
| Product code | CGA |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 7, 2008 |
| 510(k) numbers | K924475 |
| FEI number | 1823260 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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