Device recall
Z-0307-2013: bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument…
FDA device recall · Class II · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-0307-2013 |
|---|---|
| Recall event | 63467 |
| Product | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that… |
| Product code | MDB |
| Recalling firm | Biomerieux Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 28, 2013 |
| FEI number | 1950204 |
At a glance
- None 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