Device recall
Z-1478-2014: API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH…
FDA device recall · Class II · BioMerieux SA
Key facts
| Recall number (Z-number) | Z-1478-2014 |
|---|---|
| Recall event | 67820 |
| Product | API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms. |
| Product code | LIB |
| Recalling firm | BioMerieux SA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 14, 2017 |
| FEI number | 1000611339 |
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