FDA Device recall Z-1350-2023
Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pre…
- FDA Device
- Class II
- ongoing
- Published 2023-04-19
On 2023-04-19 the FDA classified a Class II recall of Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pre… by Church And Dwight, citing church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1350-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-25 |
| Published | 2023-04-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Church And Dwight |
| Distribution | US |
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)
Reason
Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no results reported on the APP screen) or to misread the analog results shown on the pregnancy test stick and may lead to misinterpretation of false positive or false negative tests by the user.
Identifiers
| code_info | All lots with the Easy Read App |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1350-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.