Device recall
Z-1267-2014: AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea…
FDA device recall · Class II · AMS Diagnostics, LLC
Key facts
| Recall number (Z-number) | Z-1267-2014 |
|---|---|
| Recall event | 67599 |
| Product | AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum. |
| Product code | NJT |
| Recalling firm | AMS Diagnostics, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 29, 2016 |
| FEI number | 3009128555 |
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