Device recall
Z-0649-05: Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800…
FDA device recall · Class III · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-0649-05 |
|---|---|
| Recall event | 31056 |
| Product | Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322. |
| Product code | LCP |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 17, 2005 |
| 510(k) numbers | K003120 |
| 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