Device recall
Z-2391-2018: NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy…
FDA device recall · Class II · Ekla Corporation
Key facts
| Recall number (Z-number) | Z-2391-2018 |
|---|---|
| Recall event | 80110 |
| Product | NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test |
| Product code | JHI |
| Recalling firm | Ekla Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 29, 2023 |
| 510(k) numbers | K112101 |
| FEI number | 3008733163 |
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