Device recall
Z-1358-06: ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and…
FDA device recall · Class II · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-1358-06 |
|---|---|
| Recall event | 35022 |
| Product | ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both with meter model number 2138930. |
| Product code | CGA |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 7, 2008 |
| 510(k) numbers | K930979 |
| 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