Device recall
Z-0098-06: Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part…
FDA device recall · Class II · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-0098-06 |
|---|---|
| Recall event | 31372 |
| Product | Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003. |
| Product code | GJS |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 6, 2006 |
| 510(k) numbers | K021190, K030845 |
| FEI number | 1823260 |
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