Device recall
Z-2346-2019: ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic…
FDA device recall · Class II · Aniara Diagnostica LLC
Key facts
| Recall number (Z-number) | Z-2346-2019 |
|---|---|
| Recall event | 83487 |
| Product | ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. |
| Product code | LCO |
| Recalling firm | Aniara Diagnostica LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 11, 2021 |
| 510(k) numbers | K071255 |
| FEI number | 3005017664 |
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