Device recall
Z-0023-2013: PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham…
FDA device recall · Class II · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-0023-2013 |
|---|---|
| Recall event | 63019 |
| Product | PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples. |
| Product code | LXG |
| Recalling firm | Biomerieux Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 4, 2014 |
| FEI number | 1950204 |
At a glance
- None 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