Device recall
Z-0843-2014: API NH (REF 10400) API NH is a standardized system for the identification of…
FDA device recall · Class II · Biomerieux France Chemin De L'Or
Key facts
| Recall number (Z-number) | Z-0843-2014 |
|---|---|
| Recall event | 66931 |
| Product | API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus… |
| Recalling firm | Biomerieux France Chemin De L'Or |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 30, 2017 |
| FEI number | 1000611339 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
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