Device recall
Z-1475-2014: ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to…
FDA device recall · Class II · BioMerieux SA
Key facts
| Recall number (Z-number) | Z-1475-2014 |
|---|---|
| Recall event | 67820 |
| Product | ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of… |
| 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