Device recall
Z-1350-2023: Easy Read App associated with First Response Pregnancy Test Sticks - Intended…
FDA device recall · Class II · Church & Dwight Inc
Key facts
| Recall number (Z-number) | Z-1350-2023 |
|---|---|
| Recall event | 91758 |
| Product | Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad) |
| Product code | LCX |
| Recalling firm | Church & Dwight Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K083716 |
| FEI number | 2280705 |
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