Device recall
Z-0164-2016: Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia…
FDA device recall · Class II · Sentinel CH SpA
Key facts
| Recall number (Z-number) | Z-0164-2016 |
|---|---|
| Recall event | 72311 |
| Product | Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma. |
| Product code | JIF |
| Recalling firm | Sentinel CH SpA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 30, 2016 |
| 510(k) numbers | K051114 |
| FEI number | 3000303338 |
At a glance
- 1–9 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