Device recall
Z-0650-05: Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number…
FDA device recall · Class III · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-0650-05 |
|---|---|
| Recall event | 31056 |
| Product | Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322. |
| Product code | LCP |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 17, 2005 |
| 510(k) numbers | K952337 |
| 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