Device recall
Z-1078-2017: Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For…
FDA device recall · Class II · Sekisui Diagnostics P.E.I. Inc.
Key facts
| Recall number (Z-number) | Z-1078-2017 |
|---|---|
| Recall event | 75818 |
| Product | Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma |
| Product code | JIF |
| Recalling firm | Sekisui Diagnostics P.E.I. Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 6, 2017 |
| 510(k) numbers | K033921 |
| FEI number | 3002806809 |
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